Showing posts with label International Adhesion Society. Show all posts
Showing posts with label International Adhesion Society. Show all posts
Tuesday, December 17, 2013
Tuesday, January 17, 2012
Adhesion related Disorder ~ Adhesion Products Adhesion Reduction Agents
Adhesion Products
Please Note:
Information provided here is intended as a lay overview only and not as any fort of endorsement. Any product described here must be used by a medical doctorin accordance with the Instructions for Use and after taking a Patient's individual circumstances into account.
Reposted from the International Adhesion Society. Please visit the International Adhesion Society at;
http://www.adhesions.org/
--------------------------------------------------------------------------------
http://www.adhesions.org/products.htm
Products Approved by FDA for Adhesion Prevention, Reduction in Pelvice and/or Abdominal Cavities
* INTERCEED (TC7), made by Johnson & Johnson
Placed over the site of surgical injury, this knitted fabric dissolves within 30 days or so. The idea is that the sheet keeps organs apart that would otherwise stick (adhere) together. Once healing is complete, the sheet dissolves leaving the two organs properly separated.
Since 1989, it has been approved only for open (non-keyhole) gynecologic surgery with a good record of safety and effectiveness documented in this paper authored by Dr. Wiseman in 1999.
Althought it is not approved in the USA for use in laparoscopice (key-hole) surgery, INTERCEED is often used "off-label". Only small clinical studies to evaluate INTERCEED in laparoscopy have been performed with mixed results, possibly because almost perfect control of bleeding (required for INTERCEED's action) may not have been achieved, or INTERCEED was dislodged from its site of placement.
Early studies suggested that a small amount of Heparin added to the INTERCEED may not only enhance its action, but also overcome the detrimental effect that bleeding has on the beneficial action of INTERCEED. Unfortunately, this work was never pursued, neither was a modified form of INTERCEED, which also functioned better than the original INTERCEED, both in the absence and presence of bleeding.
* Seprafilm, made by Genzyme (previously called HAL-F)
This film looks like a thin, slightly brittle clear "fruit roll-up" that gels soon after contact with moist body tissues. It workes and is used in much the same way as INTERCEED, except that it is also approved for General Surgery. Like INTERCEED, it is not approved in the USA for laparoscopic use, aothought with considerable technical difficulty, it can be applied in laparoscopic surgery "off-label". Approved in 1996, it has now had a long history of safety and effectiveness similar to that of INTERCEED and a number of studies have preorted its use in a variety of procedures as well as the reduction of obstruction in some cases. It should not be wrapped around the bowel that has been cut open.
Some surgeons have made a gel by cutting small pieces of Seprafilm and mixing them with saline. A study conducted by Genzyme with a standard preparation called "SepraSpray" has yielded what appear to be unimpressive results.
* Adept, marketed by Baxter
Adept is a solution containing a carbohydrate polymer. A large volume (about 3 liters) is instilled into the abdominal cavity after surgery causing them to float, keeping them apart and and preventing them from sticking to each other. Because of the the composition of the product, liquid stays in the abdominal cavity for several more days that plain saline (salt) solutions commonly used by surgeons. Altough, it has the advantage that it is easy to apply and it can be used laparoscopically, the clinical data suggest that its effectiveness is at best marginally better than salt solutions, also when used in large volume.
It should be noted that small (eg 300ml) volumes of saline used to float tissues apart do not appear to reduce adhesions, thus the data from the Adept study does suggest that large volumes of physiological saline solutions may have some benefit in reducing adhesions.
--------------------------------------------------------------------------------
Products not approved for Adhesions prevention, but often used "off-label" (USA)
*Note that some of these products may be approved in countries other than the USA for adhesion prevention.
* Evicel - made by Johnson & Johnson
Evicel is a type of "Fibrin Glue", a two component product made from naturally occurring molecules extracted from human blood. It is mainly used to control bleeding during surgery. A number of studies in animals and humans have suggested that fibrin glues of various types can reduce adhesions. One study using a similar, but not identical experimental version of Evicel did suggest that indeed this type of fibrin glue may reduce adhesions in humans.
Evicel has the advantage that is can easily be applied laparoscopically, it can be spayed over a large area, is a naturally occurring material and can control mild bleeding.
Other types of fibrin glue, such as Tisseel and Tissucol, made by Baxter has also been used by some surgeons to reduce adhesions.
Note - there are a number of important differences between different types of fibrin glue that could determine how effective each type is.
* Coseal, made by Baxter
Coseal is a two-component, synthetic product used to seal leakage after surgery on blood vessels. It has been sprayed or applied over areas of surgical injury to reduce adhesions both in animal models and in one human trial with 71 patients undergoing myomectomy.
Coseal is marketed in Europe not only as a sealant, but also to prevent or reduce post surgical adhesions. Coseal is the same as what was formerly known as Adhibit.
* Surgiwrap, made by MAST BioSurgery
SurgiWrap (and its cousins OrthoWrap and CardioWrap) is a clear thin sheet of a dissolvable polymer similar to the kind used in dissolvable sutures. Full clinical studies of the kind conducted for INTERCEED or Seprafilm showing that it prevents or reduces adhesions have not been published and the product is approved in the USA to “reinforce soft tissues where weakness exists”.
Based primarily on animal studies and due to technicalities in the regulation of medical devices in the USA, the company’s marketing literature for the USA states that the product “Maintains a physical barrier between opposing soft tissues” and “Retains tensile strength for 6-8 weeks ensuring tissue separation during the critical wound healing period” and implies that the product reduces or minimizes “Soft Tissue Attachments”. The company’s literature for Surgiwrap intended for marketing outside the USA clearly claims that that SurgiWrap “prevents adhesion formation”. Naturally this difference has come to the attention of American surgeons who have traveled abroad and combined with a number of reports of adverse events such as the presence of a tissue reaction and the emergence of fragments of the sheet through the vagina which in one case was reported to have “lacerated her partner”, the product does not seem to enjoy popular use.
* PRECLUDE Peritoneal Membrane made by WL Gore
This product is being discontinued after December 2011. It never had the same kind of formal approval in the USA that INTERCEED, Seprafilm or ADEPT did of adhesion prevention, but after enjoying a fairly long period of use to reconstruct tissues, for example in hernia repair, the claim was added sometime in the early 1990s “for use in peritoneal reconstruction where minimal adhesions to a prosthetic material are desired”. PRECLUDE is a thin sheet of porous ePTFE (Teflon). Although some studies showed in the 1990s that Preclude (previously known as GoreTex surgical Membrane) reduced adhesions, many surgeons were reluctant to use it since it did not degrade and required a subsequent operation to remove it.
Versions of the product to minimize adhesions in cardiac and cranial (dural) surgery.
Drugs for Adhesion Prevention
There are no drugs currently approved for the prevention or removal of adhesions. Research in this area, most of it in animals, has focused mainly on drugs that can be applied directly into the abdominal cavity at the time of surgery. Most of the drugs tested have been directed either at the clotting process (preventing or reversing the deposition of fibrin - the natural glue that causes the initial attachment or adhesion of tissues) or the inflammatory process (which results in the formation of scar).
Some promising clinical data did suggest that heparin, when applied to INTERCEED may not only enhance its action but also overcome the detrimental effect that bleeding has on the beneficial action of INTERCEED. This was never pursued formally. Data from the pivotal general surgical trial for Seprafilm in patients with ulcerative colitis undergoing bowel surgery did suggest that patients receiving long term corticosteroids prior to surgery had lower rates of adhesion formation than those that did not. The effect was best seen in patients also receiving Seprafilm.
Studies, never published but widely known to have been performed in the 1980s and 1990s using Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen and tolmetin applied as solutions to the peritoneal cavity failed to result in the use of these drugs clinically.
tPA (Tissue Plasminogen Activiator) is a drug causes the dissolution of fibrin. Several small pilot studies had been performed but never pursued and a recent study failed to show a difference between treatment and control groups.
Newer generations of these classes of drugs have been tested in animals, bit so far without any formal clinical trials. Other classes of drugs tested include anti-oxidants, anti-angiogenic drugs, anti-fibrotic drugs, hormonal drugs, cytokine inhibitors, anti-inflammatory cytokines and COX-2 inhibitors.
Hernia and Tissue Reconstruction Meshes
A number of products exist for the reinforcement of soft tissues after major dissections, including hernias. Adhesions to these meshes is a common problem and the designers of some products have attempted to reduce this problem. These products may feature claims akin to those of the Preclude products and include (not exhaustively): Sepramesh (Davol) and PROCEED (Johnson & Johnson).
These and other surgical meshes may be used not only in hernia repair but also for Pelvic Organ Prolapse and Stress Urinary Incontinence. Regarding these kinds of products in general, FDA has issued a Public Health Notification on October 20 2008. There was also an update on July 13, 2011 regarding complications associated with some of these meshes that when used for hernia repair complications include “adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels . Other complications of hernia repair can occur with or without the mesh, including infection, chronic pain and hernia recurrence.”
When used for Pelvic Organ Prolapse and Stress Urinary Incontinence the “most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence. In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels.”
Since serious complications may occur with the use of Surgical Meshes it is important that you discuss with your doctor the risks and benefits of meshes as well as the type of mesh you may be given and its likelihood of producing an adverse reaction.
Other Products of Interest
* INSUFLOW, made by Lexion Medical
This novel device warms and humidifies the gases used to inflate the abdominal cavity during laparoscopic surgery. Because these cold, dry gases (carbon dioxide) are pumped at pressure they create a “wind-chill effect” which damages the surface layer (peritoneum) of organs in the abdominal cavity, a finding made in a study by Dr. Wiseman
Although the company does not claim it, it is well accepted that damage to the peritoneal layer contributes to the formation of adhesions. In addition use of the device helps to reduce hypothermia, postoperative pain and recovery time after surgery.
Products Marketed Outside of the USA
* SprayGel and SprayShield, made by Covidien
SprayShield is a synthetic two component product that forms a gel when applied to an organ. It is a modified version of SprayGel which demonstrated clinical effectiveness in reducing adhesions in small studies involving gynecologicand general surgery
Although all the details are unclear, it seems that SprayGel was discontinued because of problems relating to possible adverse reasons and the ability of the gel to form properly in the carbon dioxide environment that is used in laparoscopic surgery. SprayGel was, and SprayShield is marketed in Europe and we understand that a recent clinical trial in the USA was discontinued because the product failed to demonstrate efficacy.
* Hyalobarrier and Hyalobarrier Endo, made by Fidia Advanced Biopolymers, now Anika Therapeutics
Hyalobarrier, sometimes referred to as ACP Gel, is made from hyaluronic acid, a naturally occurring lubricant in the body.
Some small clinical trials have demonstrated effectiveness of in gynecologic surgery
* INTERCOAT, also known as Oxiplex AP made by Johnson & Johnson, licensed from Fziomed
This gel made is applied directly to raw surgical surfaces. Efficacy in gynecologic study was demonstrated in two small studies.
Study 1
Study 2
* Prevadh, made by Sofradim-Covidien in France
A collagen film and fleece composite that in animals was able to reduce adhesions even in the presence of bleeding and appeared safe in an uncontrolled clinical study of 78 patients.
--------------------------------------------------------------------------------
Products Marketed for reducing adhesions in procedures outside of the abdominal or pelvic cavities.
(This is not an exhaustive list, and it also includes products that have no formal claim of adhesion prevention)
Products (USA) Company Composition Indication
Repel CV Synthemed PLA/PEO Cardiac
TENOGLIDE Integra Collagen Tendon
Sepragel ENT
Seprapack
Genzyme Hyaluronic Acid Nasal / Sinus
Preclude Pericardial Gore ePTFE Pericardial
Preclude Dura Substitute Gore ePTFE
Products (non-USA) Company Composition Indication
INCERT-S Anika Hyaluronic Acid Spinal Surgery
ACP Gel Fidia Hyaluronic Acid Uterine Adhesions
MeroGel Fidia Hyaluronic Acid ENT
Oxiplex (also Medishield) Fziomed CMC/PEO Spinal
ADCON L Bioscompass Dextran Sulphate Spinal Surgery
ADCON T/N Biocompass Dextran Sulphate Tendon & Nerve Surgery
Products where data exists for prevention of clinical outcomes related to adhesions
Note that products may or may not have regulatory approval to market their products based on these studies. Only a selection of positive studies are shown below.
Prevention of IntraUterine Adhesions
Seprafilm Tsapanos et al., 2002
SprayGel Abbott et al., 2004
ACP Gel Guida et al., 2004
ACP Gel Acunzo et al., 2003
Intercoat Sardo et al., 2011
Prevention of adhesions after C Section
Seprafilm Fushiki H; Ikoma T; Kobayashi H, and Yoshimoto H. Efficacy of Seprafilm as an Adhesion Barrier in Cesarean Sections. Obstetric and Gynecological Treatment [Japanese]. 2005; 91(5):557-561.
Reduction of pain after adhesion-related surgery
Seprafilm Khaitan et al., 2003
Reduction of bowel obstruction
Seprafilm
Mohri et al., 2005
Fazio et al., 2006
Products where data exists for improvement of fertility after adhesion-related surgery (not necessarily with regulatory approval)
INTERCEED Sawada et al.,2000
Discontinued Products
* Sepracoat (also HAL-C), made by Genzyme was a hyaluronic acid based liquid that was used to coat tissue surfaces during surgery. It demonstrated clinical efficacy against de novo adhesions caused by tissue handling.
Its approval in the USA was rejected, and the product sold for a short time in Europe before poor sales led to its voluntary discontinuation sometime around 2000.
* INTERGEL, made by LifeCore, marketed by Johnson & Johnson was a gel of hyaluronic acid cross-linked with iron. With demonstration of clinical efficacy in the US and Europe .long it received FDA approval in 2002 after an unusual and controversial route but was withdrawn about one year later after reports of tissue reactions, increased rates of infection, late onset pain and some deaths.
Research conducted by the IAS suggested that these effects may have been more prevalent in patients who carried gene mutations for Haemochromatosis, a disorder of iron regulation, or women who had had prior hysterectomies, possibly because of an increased tendency to accumulate iron. Additional article.
* ADCON L is a gel containing Dextran Sulphate made by Gliatech for use in spinal surgery. It was approved by FDA in 1997. A version for tendon and nerve surgery was available in Europe and after a successful preclinical study conducted by Dr. Wiseman, a clinical trial, also designed by Dr. Wiseman had began to show promising results in pelvic surgery. Rapid sales of the ADCON L product began to be marred by a series of issues relating to problems in manufacturing, the company’s failure to report adverse events, and their alleged manipulation of data in a clinical trial. The company essentially placed in a “regulatory” limbo by FDA until it could, to FDA’s satisfaction put its house in order. A new management did indeed do this, but the effect of the FDA action forced the company to declare bankruptcy in 2002. Although not available in the USA, the product continues to be sold in Europe and elsewhere both in the ADCON L version and the ADCON T/N (tendon and nerve) version.
* Hyskon, made by Pharmacia, was a syrupy liquid used to expand the uterus during hysteroscpic evaluation. In the mid 1980s its was used off-label in the USA to prevent adhesions by pouring it into the abdominal cavity in the aim that it would lubricate raw tissue surfaces and prevent them from sticking. Some studies provided somewhat positive data, and while others provided the reverse and concerns of adverse reactions as well the emergence of other barriers led to its demise.
Adverse Reactions
Information about adverse reactions reported to FDA can be obtained through:
MAUDE - Manufacturer and User Facility Device Experience
If you think you have suffered an adverse reaction to any medical product, you should certainly contact your doctor and if necessary call the Emergency Services or go to the nearest Emergency Room. You are also free to report the event to the FDA by contacting the FDA's MedWatch Adverse Event Reporting program either online, by mail or FAX.
Online : MedWatch Online Voluntary Reporting Form (3500)
Mail : use postage-paid FDA form 3500 available at: MedWatch Forms
Mail to:
MedWatch
5600 Fishers Lane,
Rockville, MD 20852-9787
FAX: 1-800-FDA-0178
Interested in participating in a clinical trial?
Go to ClincalTrials.gov to search for clinical trials relating to adhesions, or any other therapeutic area.
Please Note:
Information provided here is intended as a lay overview only and not as any fort of endorsement. Any product described here must be used by a medical doctorin accordance with the Instructions for Use and after taking a Patient's individual circumstances into account.
Reposted from the International Adhesion Society. Please visit the International Adhesion Society at;
http://www.adhesions.org/
--------------------------------------------------------------------------------
http://www.adhesions.org/products.htm
Products Approved by FDA for Adhesion Prevention, Reduction in Pelvice and/or Abdominal Cavities
* INTERCEED (TC7), made by Johnson & Johnson
Placed over the site of surgical injury, this knitted fabric dissolves within 30 days or so. The idea is that the sheet keeps organs apart that would otherwise stick (adhere) together. Once healing is complete, the sheet dissolves leaving the two organs properly separated.
Since 1989, it has been approved only for open (non-keyhole) gynecologic surgery with a good record of safety and effectiveness documented in this paper authored by Dr. Wiseman in 1999.
Althought it is not approved in the USA for use in laparoscopice (key-hole) surgery, INTERCEED is often used "off-label". Only small clinical studies to evaluate INTERCEED in laparoscopy have been performed with mixed results, possibly because almost perfect control of bleeding (required for INTERCEED's action) may not have been achieved, or INTERCEED was dislodged from its site of placement.
Early studies suggested that a small amount of Heparin added to the INTERCEED may not only enhance its action, but also overcome the detrimental effect that bleeding has on the beneficial action of INTERCEED. Unfortunately, this work was never pursued, neither was a modified form of INTERCEED, which also functioned better than the original INTERCEED, both in the absence and presence of bleeding.
* Seprafilm, made by Genzyme (previously called HAL-F)
This film looks like a thin, slightly brittle clear "fruit roll-up" that gels soon after contact with moist body tissues. It workes and is used in much the same way as INTERCEED, except that it is also approved for General Surgery. Like INTERCEED, it is not approved in the USA for laparoscopic use, aothought with considerable technical difficulty, it can be applied in laparoscopic surgery "off-label". Approved in 1996, it has now had a long history of safety and effectiveness similar to that of INTERCEED and a number of studies have preorted its use in a variety of procedures as well as the reduction of obstruction in some cases. It should not be wrapped around the bowel that has been cut open.
Some surgeons have made a gel by cutting small pieces of Seprafilm and mixing them with saline. A study conducted by Genzyme with a standard preparation called "SepraSpray" has yielded what appear to be unimpressive results.
* Adept, marketed by Baxter
Adept is a solution containing a carbohydrate polymer. A large volume (about 3 liters) is instilled into the abdominal cavity after surgery causing them to float, keeping them apart and and preventing them from sticking to each other. Because of the the composition of the product, liquid stays in the abdominal cavity for several more days that plain saline (salt) solutions commonly used by surgeons. Altough, it has the advantage that it is easy to apply and it can be used laparoscopically, the clinical data suggest that its effectiveness is at best marginally better than salt solutions, also when used in large volume.
It should be noted that small (eg 300ml) volumes of saline used to float tissues apart do not appear to reduce adhesions, thus the data from the Adept study does suggest that large volumes of physiological saline solutions may have some benefit in reducing adhesions.
--------------------------------------------------------------------------------
Products not approved for Adhesions prevention, but often used "off-label" (USA)
*Note that some of these products may be approved in countries other than the USA for adhesion prevention.
* Evicel - made by Johnson & Johnson
Evicel is a type of "Fibrin Glue", a two component product made from naturally occurring molecules extracted from human blood. It is mainly used to control bleeding during surgery. A number of studies in animals and humans have suggested that fibrin glues of various types can reduce adhesions. One study using a similar, but not identical experimental version of Evicel did suggest that indeed this type of fibrin glue may reduce adhesions in humans.
Evicel has the advantage that is can easily be applied laparoscopically, it can be spayed over a large area, is a naturally occurring material and can control mild bleeding.
Other types of fibrin glue, such as Tisseel and Tissucol, made by Baxter has also been used by some surgeons to reduce adhesions.
Note - there are a number of important differences between different types of fibrin glue that could determine how effective each type is.
* Coseal, made by Baxter
Coseal is a two-component, synthetic product used to seal leakage after surgery on blood vessels. It has been sprayed or applied over areas of surgical injury to reduce adhesions both in animal models and in one human trial with 71 patients undergoing myomectomy.
Coseal is marketed in Europe not only as a sealant, but also to prevent or reduce post surgical adhesions. Coseal is the same as what was formerly known as Adhibit.
* Surgiwrap, made by MAST BioSurgery
SurgiWrap (and its cousins OrthoWrap and CardioWrap) is a clear thin sheet of a dissolvable polymer similar to the kind used in dissolvable sutures. Full clinical studies of the kind conducted for INTERCEED or Seprafilm showing that it prevents or reduces adhesions have not been published and the product is approved in the USA to “reinforce soft tissues where weakness exists”.
Based primarily on animal studies and due to technicalities in the regulation of medical devices in the USA, the company’s marketing literature for the USA states that the product “Maintains a physical barrier between opposing soft tissues” and “Retains tensile strength for 6-8 weeks ensuring tissue separation during the critical wound healing period” and implies that the product reduces or minimizes “Soft Tissue Attachments”. The company’s literature for Surgiwrap intended for marketing outside the USA clearly claims that that SurgiWrap “prevents adhesion formation”. Naturally this difference has come to the attention of American surgeons who have traveled abroad and combined with a number of reports of adverse events such as the presence of a tissue reaction and the emergence of fragments of the sheet through the vagina which in one case was reported to have “lacerated her partner”, the product does not seem to enjoy popular use.
* PRECLUDE Peritoneal Membrane made by WL Gore
This product is being discontinued after December 2011. It never had the same kind of formal approval in the USA that INTERCEED, Seprafilm or ADEPT did of adhesion prevention, but after enjoying a fairly long period of use to reconstruct tissues, for example in hernia repair, the claim was added sometime in the early 1990s “for use in peritoneal reconstruction where minimal adhesions to a prosthetic material are desired”. PRECLUDE is a thin sheet of porous ePTFE (Teflon). Although some studies showed in the 1990s that Preclude (previously known as GoreTex surgical Membrane) reduced adhesions, many surgeons were reluctant to use it since it did not degrade and required a subsequent operation to remove it.
Versions of the product to minimize adhesions in cardiac and cranial (dural) surgery.
Drugs for Adhesion Prevention
There are no drugs currently approved for the prevention or removal of adhesions. Research in this area, most of it in animals, has focused mainly on drugs that can be applied directly into the abdominal cavity at the time of surgery. Most of the drugs tested have been directed either at the clotting process (preventing or reversing the deposition of fibrin - the natural glue that causes the initial attachment or adhesion of tissues) or the inflammatory process (which results in the formation of scar).
Some promising clinical data did suggest that heparin, when applied to INTERCEED may not only enhance its action but also overcome the detrimental effect that bleeding has on the beneficial action of INTERCEED. This was never pursued formally. Data from the pivotal general surgical trial for Seprafilm in patients with ulcerative colitis undergoing bowel surgery did suggest that patients receiving long term corticosteroids prior to surgery had lower rates of adhesion formation than those that did not. The effect was best seen in patients also receiving Seprafilm.
Studies, never published but widely known to have been performed in the 1980s and 1990s using Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen and tolmetin applied as solutions to the peritoneal cavity failed to result in the use of these drugs clinically.
tPA (Tissue Plasminogen Activiator) is a drug causes the dissolution of fibrin. Several small pilot studies had been performed but never pursued and a recent study failed to show a difference between treatment and control groups.
Newer generations of these classes of drugs have been tested in animals, bit so far without any formal clinical trials. Other classes of drugs tested include anti-oxidants, anti-angiogenic drugs, anti-fibrotic drugs, hormonal drugs, cytokine inhibitors, anti-inflammatory cytokines and COX-2 inhibitors.
Hernia and Tissue Reconstruction Meshes
A number of products exist for the reinforcement of soft tissues after major dissections, including hernias. Adhesions to these meshes is a common problem and the designers of some products have attempted to reduce this problem. These products may feature claims akin to those of the Preclude products and include (not exhaustively): Sepramesh (Davol) and PROCEED (Johnson & Johnson).
These and other surgical meshes may be used not only in hernia repair but also for Pelvic Organ Prolapse and Stress Urinary Incontinence. Regarding these kinds of products in general, FDA has issued a Public Health Notification on October 20 2008. There was also an update on July 13, 2011 regarding complications associated with some of these meshes that when used for hernia repair complications include “adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels . Other complications of hernia repair can occur with or without the mesh, including infection, chronic pain and hernia recurrence.”
When used for Pelvic Organ Prolapse and Stress Urinary Incontinence the “most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence. In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels.”
Since serious complications may occur with the use of Surgical Meshes it is important that you discuss with your doctor the risks and benefits of meshes as well as the type of mesh you may be given and its likelihood of producing an adverse reaction.
Other Products of Interest
* INSUFLOW, made by Lexion Medical
This novel device warms and humidifies the gases used to inflate the abdominal cavity during laparoscopic surgery. Because these cold, dry gases (carbon dioxide) are pumped at pressure they create a “wind-chill effect” which damages the surface layer (peritoneum) of organs in the abdominal cavity, a finding made in a study by Dr. Wiseman
Although the company does not claim it, it is well accepted that damage to the peritoneal layer contributes to the formation of adhesions. In addition use of the device helps to reduce hypothermia, postoperative pain and recovery time after surgery.
Products Marketed Outside of the USA
* SprayGel and SprayShield, made by Covidien
SprayShield is a synthetic two component product that forms a gel when applied to an organ. It is a modified version of SprayGel which demonstrated clinical effectiveness in reducing adhesions in small studies involving gynecologicand general surgery
Although all the details are unclear, it seems that SprayGel was discontinued because of problems relating to possible adverse reasons and the ability of the gel to form properly in the carbon dioxide environment that is used in laparoscopic surgery. SprayGel was, and SprayShield is marketed in Europe and we understand that a recent clinical trial in the USA was discontinued because the product failed to demonstrate efficacy.
* Hyalobarrier and Hyalobarrier Endo, made by Fidia Advanced Biopolymers, now Anika Therapeutics
Hyalobarrier, sometimes referred to as ACP Gel, is made from hyaluronic acid, a naturally occurring lubricant in the body.
Some small clinical trials have demonstrated effectiveness of in gynecologic surgery
* INTERCOAT, also known as Oxiplex AP made by Johnson & Johnson, licensed from Fziomed
This gel made is applied directly to raw surgical surfaces. Efficacy in gynecologic study was demonstrated in two small studies.
Study 1
Study 2
* Prevadh, made by Sofradim-Covidien in France
A collagen film and fleece composite that in animals was able to reduce adhesions even in the presence of bleeding and appeared safe in an uncontrolled clinical study of 78 patients.
--------------------------------------------------------------------------------
Products Marketed for reducing adhesions in procedures outside of the abdominal or pelvic cavities.
(This is not an exhaustive list, and it also includes products that have no formal claim of adhesion prevention)
Products (USA) Company Composition Indication
Repel CV Synthemed PLA/PEO Cardiac
TENOGLIDE Integra Collagen Tendon
Sepragel ENT
Seprapack
Genzyme Hyaluronic Acid Nasal / Sinus
Preclude Pericardial Gore ePTFE Pericardial
Preclude Dura Substitute Gore ePTFE
Products (non-USA) Company Composition Indication
INCERT-S Anika Hyaluronic Acid Spinal Surgery
ACP Gel Fidia Hyaluronic Acid Uterine Adhesions
MeroGel Fidia Hyaluronic Acid ENT
Oxiplex (also Medishield) Fziomed CMC/PEO Spinal
ADCON L Bioscompass Dextran Sulphate Spinal Surgery
ADCON T/N Biocompass Dextran Sulphate Tendon & Nerve Surgery
Products where data exists for prevention of clinical outcomes related to adhesions
Note that products may or may not have regulatory approval to market their products based on these studies. Only a selection of positive studies are shown below.
Prevention of IntraUterine Adhesions
Seprafilm Tsapanos et al., 2002
SprayGel Abbott et al., 2004
ACP Gel Guida et al., 2004
ACP Gel Acunzo et al., 2003
Intercoat Sardo et al., 2011
Prevention of adhesions after C Section
Seprafilm Fushiki H; Ikoma T; Kobayashi H, and Yoshimoto H. Efficacy of Seprafilm as an Adhesion Barrier in Cesarean Sections. Obstetric and Gynecological Treatment [Japanese]. 2005; 91(5):557-561.
Reduction of pain after adhesion-related surgery
Seprafilm Khaitan et al., 2003
Reduction of bowel obstruction
Seprafilm
Mohri et al., 2005
Fazio et al., 2006
Products where data exists for improvement of fertility after adhesion-related surgery (not necessarily with regulatory approval)
INTERCEED Sawada et al.,2000
Discontinued Products
* Sepracoat (also HAL-C), made by Genzyme was a hyaluronic acid based liquid that was used to coat tissue surfaces during surgery. It demonstrated clinical efficacy against de novo adhesions caused by tissue handling.
Its approval in the USA was rejected, and the product sold for a short time in Europe before poor sales led to its voluntary discontinuation sometime around 2000.
* INTERGEL, made by LifeCore, marketed by Johnson & Johnson was a gel of hyaluronic acid cross-linked with iron. With demonstration of clinical efficacy in the US and Europe .long it received FDA approval in 2002 after an unusual and controversial route but was withdrawn about one year later after reports of tissue reactions, increased rates of infection, late onset pain and some deaths.
Research conducted by the IAS suggested that these effects may have been more prevalent in patients who carried gene mutations for Haemochromatosis, a disorder of iron regulation, or women who had had prior hysterectomies, possibly because of an increased tendency to accumulate iron. Additional article.
* ADCON L is a gel containing Dextran Sulphate made by Gliatech for use in spinal surgery. It was approved by FDA in 1997. A version for tendon and nerve surgery was available in Europe and after a successful preclinical study conducted by Dr. Wiseman, a clinical trial, also designed by Dr. Wiseman had began to show promising results in pelvic surgery. Rapid sales of the ADCON L product began to be marred by a series of issues relating to problems in manufacturing, the company’s failure to report adverse events, and their alleged manipulation of data in a clinical trial. The company essentially placed in a “regulatory” limbo by FDA until it could, to FDA’s satisfaction put its house in order. A new management did indeed do this, but the effect of the FDA action forced the company to declare bankruptcy in 2002. Although not available in the USA, the product continues to be sold in Europe and elsewhere both in the ADCON L version and the ADCON T/N (tendon and nerve) version.
* Hyskon, made by Pharmacia, was a syrupy liquid used to expand the uterus during hysteroscpic evaluation. In the mid 1980s its was used off-label in the USA to prevent adhesions by pouring it into the abdominal cavity in the aim that it would lubricate raw tissue surfaces and prevent them from sticking. Some studies provided somewhat positive data, and while others provided the reverse and concerns of adverse reactions as well the emergence of other barriers led to its demise.
Adverse Reactions
Information about adverse reactions reported to FDA can be obtained through:
MAUDE - Manufacturer and User Facility Device Experience
If you think you have suffered an adverse reaction to any medical product, you should certainly contact your doctor and if necessary call the Emergency Services or go to the nearest Emergency Room. You are also free to report the event to the FDA by contacting the FDA's MedWatch Adverse Event Reporting program either online, by mail or FAX.
Online : MedWatch Online Voluntary Reporting Form (3500)
Mail : use postage-paid FDA form 3500 available at: MedWatch Forms
Mail to:
MedWatch
5600 Fishers Lane,
Rockville, MD 20852-9787
FAX: 1-800-FDA-0178
Interested in participating in a clinical trial?
Go to ClincalTrials.gov to search for clinical trials relating to adhesions, or any other therapeutic area.
Friday, November 04, 2011
Innocoll Announces European Approval for CollaGUARD®, Surgical Adhesion Barrier
ASHBURN, Va., Oct. 11, 2011 /PRNewswire/ -- Innocoll, Inc. announces the approval of CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic surgery. The product will be launched this year through a network of distribution partnerships. The company also plans to seek approval in a number of additional territories, including Australia, Canada, the MENA region, South East Asia, and to initiate the studies required for registration in the US.
Dr. Michael Myers, President and CEO commented, "EU registration for CollaGUARD represents an important milestone for Innocoll. This is the first significant approval for a product developed using our proprietary CollaFilm™ technology and we are on track to launch this year. With Cogenzia® ready to start Phase 3 testing and following the recent announcement of positive XaraColl® Phase 2 clinical data coupled with US/EU approval of a broad range of advanced woundcare products, Innocoll is assembling an exciting portfolio of late stage assets. We look forward to further positive developments for our products and technologies throughout 2012 and beyond."
About CollaGUARD®
CollaGUARD is a transparent bioresorbable film of 100% type I collagen that has been developed using Innocoll's proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. CollaGUARD is implanted at the time of surgery and serves as a temporary barrier to separate apposing adhesiogenic surfaces throughout the normal tissue repair process. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P < 0.001) and significantly reduced the extent and severity of adhesions (P < 0.001).
CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.
About Postoperative Adhesions
Postoperative adhesions are abnormal fibrous connections that can form between any apposing internal organ and serous membrane as a natural consequence of abdominopelvic surgery. Adhesions occur in almost 95% of laparotomies and may lead to serious complications such as intestinal obstruction, secondary female infertility, and chronic abdominal or pelvic pain. More than 30% of patients who undergo open gynecologic or general surgery are readmitted within 10 years for disorders that are considered directly or potentially related to adhesions, with an average of 2 readmissions per patient. In the United States, there are approximately 350,000 hospitalizations annually for adhesiolysis following gynecologic or abdominal surgery, which account for almost 1 million inpatient days at a cost of $2.3 billion. Even for patients without complications, adhesions originating from a previous surgery can present significant surgical challenges and additional morbidity risks in subsequent operations.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx®, CollaFilm, DermaSil™, CollaPressTM and Liquicoll®. Approved products based on the Company's technologies include: Collatamp® G, Septocoll®, CollaGUARD, Collieva®, CollaCare®, Collexa®, Zorpreva™, and LidoColl®.
Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com.
SOURCE Innocoll, Inc.
Back to top
RELATED LINKS
http://www.innocollinc.com/
http://www.prnewswire.com/news-releases/innocoll-announces-european-approval-for-collaguard-surgical-adhesion-barrier-131504353.html
Dr. Michael Myers, President and CEO commented, "EU registration for CollaGUARD represents an important milestone for Innocoll. This is the first significant approval for a product developed using our proprietary CollaFilm™ technology and we are on track to launch this year. With Cogenzia® ready to start Phase 3 testing and following the recent announcement of positive XaraColl® Phase 2 clinical data coupled with US/EU approval of a broad range of advanced woundcare products, Innocoll is assembling an exciting portfolio of late stage assets. We look forward to further positive developments for our products and technologies throughout 2012 and beyond."
About CollaGUARD®
CollaGUARD is a transparent bioresorbable film of 100% type I collagen that has been developed using Innocoll's proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. CollaGUARD is implanted at the time of surgery and serves as a temporary barrier to separate apposing adhesiogenic surfaces throughout the normal tissue repair process. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P < 0.001) and significantly reduced the extent and severity of adhesions (P < 0.001).
CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.
About Postoperative Adhesions
Postoperative adhesions are abnormal fibrous connections that can form between any apposing internal organ and serous membrane as a natural consequence of abdominopelvic surgery. Adhesions occur in almost 95% of laparotomies and may lead to serious complications such as intestinal obstruction, secondary female infertility, and chronic abdominal or pelvic pain. More than 30% of patients who undergo open gynecologic or general surgery are readmitted within 10 years for disorders that are considered directly or potentially related to adhesions, with an average of 2 readmissions per patient. In the United States, there are approximately 350,000 hospitalizations annually for adhesiolysis following gynecologic or abdominal surgery, which account for almost 1 million inpatient days at a cost of $2.3 billion. Even for patients without complications, adhesions originating from a previous surgery can present significant surgical challenges and additional morbidity risks in subsequent operations.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx®, CollaFilm, DermaSil™, CollaPressTM and Liquicoll®. Approved products based on the Company's technologies include: Collatamp® G, Septocoll®, CollaGUARD, Collieva®, CollaCare®, Collexa®, Zorpreva™, and LidoColl®.
Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com.
SOURCE Innocoll, Inc.
Back to top
RELATED LINKS
http://www.innocollinc.com/
http://www.prnewswire.com/news-releases/innocoll-announces-european-approval-for-collaguard-surgical-adhesion-barrier-131504353.html
Sunday, April 24, 2011
Experts Discuss Art of Adhesion Prevention, Fixation Methods
Many Choices for the General Surgeon, Few Clear Answers
by Gabriel Miller
New York—Adhesions, particularly those following common procedures like appendectomy or hernia repair, are among the oldest and most common surgical complications encountered. Despite more than 150 years of published clinical insight into adhesions, they remain one of the most troublesome aspects of modern surgery.
“Preventing postsurgical adhesions remains truly an art rather than a science,” said Charles E. Miller, MD, clinical associate professor of obstetrics and gynecology at the University of Illinois College of Medicine, in Chicago.
“I second that,” said Stephen Kavic, MD, assistant professor of surgery at the University of Maryland School of Medicine, in Baltimore. “This is the one area where I find my colleagues wax poetic. There was a ‘forest of adhesions’; ‘I was wading through a sea of adhesions’; ‘the adhesions looked bad but they were mere cobwebs.’ You don’t get descriptive terms like this when you talk about the colon, but you find it often with adhesions.”
Drs. Miller and Kavic were two members of a panel of experts tackling the issue of adhesions and hernia mesh, during a plenary session at the 2010 annual meeting of the Society of Laparoendoscopic Surgeons.
“Healing Gone Awry”
Every surgeon is familiar with adhesions—fibrous bands connecting tissues and organs, typically bound to the peritoneum.
The key to understanding adhesions, and the newest approaches in preventing them, said Dr. Kavic, is that they are “an abnormal variant of a normal healing process initiated by trauma.” In other words, adhesions result from healing gone slightly awry.
“When tissue is traumatized the first thing that happens is the mast cells degranulate, causing an edema and the release of histamine and a variety of cytokines that initiate an inflammatory response,” said Kathleen Rodgers, PhD, director of research in obstetrics and gynecology at the University of Southern California, Los Angeles.
After this inflammatory phase, tissue formation begins with the recruitment of fibroblasts to create an extracellular matrix at the wound site.
“With the addition of these cellular elements—fibrinogen and thrombin onto the viscera—what can happen over time is the migration of myofibroblasts that can lead to fibrin deposition and a permanent adhesion,” said Dr. Kavic.
Because adhesions are a natural process, they may be instigated by any one of many postoperative conditions. “You have a number of issues, including infection, inflammation, a foreign body, tissue injury, necrosis—all of these contribute to postoperative adhesion formation. So the point is that it’s not a one-size-fits-all or simple mechanism,” said Ray Lanzafame, MD, MBA, associate professor of surgery at the University of Rochester School of Medicine in Rochester, N.Y.
Fibrinous adhesions are temporary and disappear over time, usually without incident. However, if inflammation is continuous—which is typical in the presence of a foreign body like mesh—fibrinous material is converted to fibrous material that forms permanent adhesions of the variety that “plague us and cause a terrific amount of grief,” Dr. Kavic said.
A Common Problem
Equally familiar to the surgical community is the variety of complications that can occur as a result of permanent adhesions, most notably small bowel obstruction, chronic pain and increased operative times in subsequent procedures.
Adhesions are so common, in fact, that they are not perceived as a legitimate complication worthy of informed consent, but instead as natural sequelae that occur in more than 90% of patients following major abdominal surgery, according to one review of peritoneal adhesions (Colorectal Dis 2007;Suppl 2:35-38).
However, a recent study found that 11% of patients are hospitalized within five years of an appendectomy for suspected adhesions, Dr. Kavic said. “That’s an alarmingly high number for a common clinical condition,” he added.
For the hernia patient, there is, perhaps not surprisingly, disagreement among surgeons about the best approach to prevent adhesions. “Generally speaking, it’s still felt that the incidence of adhesions after laparoscopy is lower than [after] open procedures, and certainly is least when the mesh surface is covered in some way,” said Dr. Lanzafame. “Adhesions are more likely with TAPP [transabdominal preperitoneal] and IPOM [intraperitoneal onlay mesh] repairs as opposed to a TEP [totally extraperitoneal] type of laparoscopic herniorrhaphy,” he added.
Nevertheless, adhesions can result from any type of hernia operation. “When we take a look at any mesh and any fixation method, we can find adhesions if we look at it hard enough; so adhesions are ubiquitous when it comes to mesh placement,” said Dr. Kavic.
Strategies and Products for Adhesion Prevention
Absorbable Tacks
Currently, there are three main approaches to prevent adhesions, and in particular, mesh and point-fixation adhesions in hernia patients:
•new approaches to affixing mesh to tissue
•composite materials that combine traditional mesh with a nonadhering surface
•resorbable liquid barriers that dissolve after the risk for adhesions has passed.
Recognizing that many current meshes allow aggressive tissue ingrowth in the first weeks after hernia repair such that permanent fixation is no longer necessary in some cases, companies introduced absorbable fixation tacks. These products, which are made from polylactic acids, show significant absorption within six months and nearly complete absorption within a year.
Although several studies have shown that absorbable tacks generally reduce postoperative pain, there are fewer data on adhesion formation using absorbable tacks. One early study of laparoscopic ventral hernia repair in a pig model found no difference in tack adhesions between metal and absorbable devices (Hernia 2004;8:358-364); in contrast, a much more recent study comparing Covidien’s metal and absorbable tacks in a rat model of laparoscopic incisional hernia repair found that adhesions were significantly reduced with absorbable tacks (Surg Endosc 2010;24:1318-1324).
Biologic Glues
Lately, hernia surgeons have eschewed point fixation altogether. The most well studied of these techniques involves fixation with resorbable biologic “glues,” most of which are tissue sealants first approved for use in thoracic or cardiovascular settings.
Much of the early research with biodegradable glues was done in inguinal hernia patients, where mesh placement within tissue planes provided a more favorable environment for glue fixation. However in the past year, three studies compared glues with other fixation methods in porcine models of laparoscopic ventral or incisional hernia repair.
The first study, conducted at the University of Southern California, found no difference in tensile strength or adhesions between four fixation methods: fibrin glue alone, transfascial sutures with tacks, fibrin glue with tacks and tacks alone (Surg Endosc 2010; July 31:Epub ahead of print).
More recently, a group at Washington University School of Medicine, in St. Louis, found that three absorbable tacking devices (PermaSorb, SorbaFix and I-Clip) were significantly stronger than fibrin glue (Surg Innov 2010;17:285-290).
Finally, in a study published in January, surgeons in Vienna demonstrated that fibrin glue fixation did not differ significantly from absorbable tacks provided that specific open-porous meshes were used. Fibrin glue did not work as well with polyester mesh coated with a resorbable collagen or condensed PTFE mesh (J Am Coll Surg 2011;212:80-86).
Covidien has introduced a self-affixing mesh that uses resorbable polylactic acid “microgrips” and adheres evenly to tissue within 60 seconds, according to the company.
“They’ve actually designed it to stick, so you’ve got these polylactic acid prongs in polypropylene, where sooner or later, the polylactic acid is resorbed and you have the underlying matrix,” said Dr. Lanzafame. “It’s the surgical equivalent of Velcro.” But currently, this mesh is not configured for laparoscopic use, he said.
Laser Tissue Welding
At the forefront of fixation is laser tissue welding or soldering, a technique that Dr. Lanzafame pioneered as a result of research funded by a National Institutes of Health (NIH) grant in collaboration with Conversion Energy Enterprises at the Laser Research Laboratory at Rochester General Hospital, in Rochester, N.Y. In this approach, mesh is welded to tissue using a collagen-based solder, which is then spread completely over the mesh material. In animal models, Dr. Lanzafame demonstrated that laser soldering can be used without increasing inflammation or adhesions compared with staples.
There are several obstacles that will need to be surmounted before surgeons can use laser-welding prosthetics intraperitoneally. “There are a couple of different issues, not the least of which is getting the [collagen-derived solder] where you want it, holding it in position and having minimal trauma to the tissue,” said Dr. Lanzafame. “This process is no small trick.”
Barrier Meshes
Even if point fixation is abandoned in favor of fibrin glues or tissue welding, surgeons still will have to deal with adhesions forming on the mesh itself, or more commonly, around the perimeter of the mesh.
The current chapter in the long-running battle to reduce adhesions began 30 years ago with the work of Scott Jenkins, MD, who performed seminal comparisons of different mesh products. In 1983, Dr. Jenkins sought to characterize adhesion formation among five different materials, most of which still are used today.
The most recent leap forward involves the creation of barrier meshes, usually comprised of a solid anti-adhesive surface bound to a standard macroporous mesh. Dr. Jenkins’ original ideal of finding a material so chemically inert that adhesions would never form is probably unrealistic, but the practical difference between placing a standard macroporous mesh and a barrier mesh intraperitoneally is the difference between bluntly dissecting thin, flimsy adhesions that are easily swept off a mesh and getting bogged down in dense, vascularized fibrotic bands that require a half-hour or longer to clear.
With the introduction of microporous mesh in the early 1980s, the market for barrier meshes exploded and at least 11 barrier meshes are being manufactured for use in the United States.
As an extension of the barrier concept, more recently liquid barrier coatings have been recommended for use in hernia repairs. Last fall, a multinational, interdisciplinary consensus conference published recommendations for adhesion prevention that included advocating use of FDA-approved adhesion barriers when appropriate.
Currently, there are three FDA-approved adhesion barriers: Seprafilm (Genzyme), Adept (Baxter) and Interceed (Gynecare), each of which has benefits and drawbacks, according to the surgeons interviewed for this article.
Seprafilm, a sodium hyaluronate/carboxymethylcellulose, was the first approved by the FDA to prevent adhesions in patients undergoing laparotomy.
“It has been shown to decrease severity of adhesions—incidence has been a little bit more questionable—and adhesion reduction seems to be what it is marketed for and what it delivers,” said Dr. Kavic.
However, in a Cochrane review of published studies, reviewers found that even though adhesions were reduced, there may have been an increased risk for leaks when Seprafilm was wrapped around anastomoses, and furthermore it did not ultimately affect rates of small bowel obstruction or morbidity and mortality.
With Seprafilm, Dr. Kavic said, “we may be preventing adhesions, but at a bit of a price.”
Less well studied are the two other adhesion barriers, Adept and Interceed.
Interceed is an oxidized, regenerated cellulose barrier approved by the FDA in 1998 for reducing adhesions in open gynecologic pelvic surgery. However, Interceed has a black box warning against use in laparoscopic surgery and is specifically contraindicated as a hemostatic agent.
“It has been shown to reduce adhesions, but it doesn’t work well when there is blood,” said Dr. Kavic. “There are very few operations that I do that involve zero blood loss; most are minimal, but there is some present.”
Finally, there is Adept, a 4% icodextrin solution approved in 2006 to reduce adhesions in patients undergoing laparoscopic gynecologic surgery. The most significant point about Adept is that it carries more contraindications than the other adhesion barriers, including infection, laparotomy incision, bowel resection, appendectomy, and uniquely, allergy to cornstarch.
Although adhesion barriers represent a step forward, by no means are they the ideal agent, said Dr. Kavic.
“We have properties of the ideal anti-adhesive—it eliminates adhesions, it’s inert, it’s cheap, it’s pliable, it’s easy to apply, but we really don’t have that agent as of yet,” he said. “Seprafilm probably comes closest to the mark for general surgery, but we do not have this for the laparoscopic setting.”
Drug Therapies: The Future?
At the farthest reaches of the adhesion prevention spectrum lie systemic or medical treatments that support normal healing while limiting adhesion formation.
Drug therapies under investigation work in one of three ways, said Dr. Rodgers, the research scientist at the University of Southern California: They reduce fibrin deposition, accelerate fibrin removal or decrease the anti-inflammatory process.
“They accelerate the healing process by reducing the inflammatory response or they reduce the scaffold that adhesions are built upon,” she said. However, many of these agents affect clotting and Dr. Rodgers said there is some risk for bleeding at a time when clotting is paramount.
Dr. Rodgers said that several other agents have shown promise, including recombinant human activated protein C, a polysaccharide similar to heparin, and a recombinant tissue plasminogen activator. But like earlier medical therapies, these agents can affect blood clotting and wound healing.
“I’ve worked with most of these kinds of drugs, and again, what I’ve noticed in my animal models when I’ve given them is there is bruising and bleeding at the incision site, and there is a very low therapeutic index between efficacy and some toxicity with their use,” Dr. Rodgers said.
The problem is that these drugs are largely systemic, rather than localized, and when they are given locally, they are diluted in a wash that’s quickly removed from the wound site.
Ultimately, Dr. Rodgers believes the future of adhesion prevention is a combination of adhesion barriers and pharmacologic therapies.
“This is where the research is going,” she said. “It’s still at very early stages, and clinically no drug yet has been shown to reduce adhesions. There are barriers that are being used clinically to prevent adhesions, and they can be effective, but they are minimally effective and they have complications. We have to find something that steps up the ability of these barriers to be effective, and my recommendation would be a drug that is safe and prevents the inflammatory events that lead to the adhesion formation.”
Currently, the general surgeon, particularly for hernia repair, has an incredible armamentarium when it to comes to preventing adhesions. Despite this, adhesions continue to proliferate.
“There is a terrific volume of research that is going into the study of preventing adhesions, but there is nothing that has really been elevated above the rest as of yet,” Dr. Kavic said.
--------------------------------------------------------------------------------
Disclosure Statements
Kathleen Rodgers, PhD, is a consultant for FzioMed and has been a consultant for Atrium Medical.
Ray Lanzafame, MD, MBA, reports grant funding from the National Institutes of Health Small Business Innovation Research (SBIR) program and research equipment from Conversion Energy Enterprises, Inc. Dr. Lanzafame also is or has been a consultant for General and Plastic Surgery Devices and other panels of the Medical Devices Advisory Committee of the FDA’s Center for Devices and Radiological Health; he has done medicolegal consulting for various law firms and entities; and he has served as a consultant for various biomedical technology companies including Carestream Health, Conversion Energy Enterprises (CEE), Eastman Kodak, Lucid, Surgicon and business and venture capital groups.
Stephen Kavic, MD, reports no disclosures and no business or financial relationships that apply to hernia fixation or to adhesion prevention.
Charles Miller, MD, reports grant/research funding from Covidien and Femasys; he has served as a consultant for Ferring Pharmaceuticals, Ethicon Endo-Surgery, Ethicon Women’s Health and Urology, Boston Scientific, Care Fusion Interlace Medical, Covidien and Femasys; he serves on the speaker’s bureau for Ferring Pharmaceuticals, Ethicon Endo-Surgery, Ethicon Women’s Health and Urology, Merck and Femasys.
http://www.generalsurgerynews.com/ViewArticle.aspx?d=In%2Bthe%2BNews&d_id=69&i=March%2B2011&i_id=711&a_id=16775
by Gabriel Miller
New York—Adhesions, particularly those following common procedures like appendectomy or hernia repair, are among the oldest and most common surgical complications encountered. Despite more than 150 years of published clinical insight into adhesions, they remain one of the most troublesome aspects of modern surgery.
“Preventing postsurgical adhesions remains truly an art rather than a science,” said Charles E. Miller, MD, clinical associate professor of obstetrics and gynecology at the University of Illinois College of Medicine, in Chicago.
“I second that,” said Stephen Kavic, MD, assistant professor of surgery at the University of Maryland School of Medicine, in Baltimore. “This is the one area where I find my colleagues wax poetic. There was a ‘forest of adhesions’; ‘I was wading through a sea of adhesions’; ‘the adhesions looked bad but they were mere cobwebs.’ You don’t get descriptive terms like this when you talk about the colon, but you find it often with adhesions.”
Drs. Miller and Kavic were two members of a panel of experts tackling the issue of adhesions and hernia mesh, during a plenary session at the 2010 annual meeting of the Society of Laparoendoscopic Surgeons.
“Healing Gone Awry”
Every surgeon is familiar with adhesions—fibrous bands connecting tissues and organs, typically bound to the peritoneum.
The key to understanding adhesions, and the newest approaches in preventing them, said Dr. Kavic, is that they are “an abnormal variant of a normal healing process initiated by trauma.” In other words, adhesions result from healing gone slightly awry.
“When tissue is traumatized the first thing that happens is the mast cells degranulate, causing an edema and the release of histamine and a variety of cytokines that initiate an inflammatory response,” said Kathleen Rodgers, PhD, director of research in obstetrics and gynecology at the University of Southern California, Los Angeles.
After this inflammatory phase, tissue formation begins with the recruitment of fibroblasts to create an extracellular matrix at the wound site.
“With the addition of these cellular elements—fibrinogen and thrombin onto the viscera—what can happen over time is the migration of myofibroblasts that can lead to fibrin deposition and a permanent adhesion,” said Dr. Kavic.
Because adhesions are a natural process, they may be instigated by any one of many postoperative conditions. “You have a number of issues, including infection, inflammation, a foreign body, tissue injury, necrosis—all of these contribute to postoperative adhesion formation. So the point is that it’s not a one-size-fits-all or simple mechanism,” said Ray Lanzafame, MD, MBA, associate professor of surgery at the University of Rochester School of Medicine in Rochester, N.Y.
Fibrinous adhesions are temporary and disappear over time, usually without incident. However, if inflammation is continuous—which is typical in the presence of a foreign body like mesh—fibrinous material is converted to fibrous material that forms permanent adhesions of the variety that “plague us and cause a terrific amount of grief,” Dr. Kavic said.
A Common Problem
Equally familiar to the surgical community is the variety of complications that can occur as a result of permanent adhesions, most notably small bowel obstruction, chronic pain and increased operative times in subsequent procedures.
Adhesions are so common, in fact, that they are not perceived as a legitimate complication worthy of informed consent, but instead as natural sequelae that occur in more than 90% of patients following major abdominal surgery, according to one review of peritoneal adhesions (Colorectal Dis 2007;Suppl 2:35-38).
However, a recent study found that 11% of patients are hospitalized within five years of an appendectomy for suspected adhesions, Dr. Kavic said. “That’s an alarmingly high number for a common clinical condition,” he added.
For the hernia patient, there is, perhaps not surprisingly, disagreement among surgeons about the best approach to prevent adhesions. “Generally speaking, it’s still felt that the incidence of adhesions after laparoscopy is lower than [after] open procedures, and certainly is least when the mesh surface is covered in some way,” said Dr. Lanzafame. “Adhesions are more likely with TAPP [transabdominal preperitoneal] and IPOM [intraperitoneal onlay mesh] repairs as opposed to a TEP [totally extraperitoneal] type of laparoscopic herniorrhaphy,” he added.
Nevertheless, adhesions can result from any type of hernia operation. “When we take a look at any mesh and any fixation method, we can find adhesions if we look at it hard enough; so adhesions are ubiquitous when it comes to mesh placement,” said Dr. Kavic.
Strategies and Products for Adhesion Prevention
Absorbable Tacks
Currently, there are three main approaches to prevent adhesions, and in particular, mesh and point-fixation adhesions in hernia patients:
•new approaches to affixing mesh to tissue
•composite materials that combine traditional mesh with a nonadhering surface
•resorbable liquid barriers that dissolve after the risk for adhesions has passed.
Recognizing that many current meshes allow aggressive tissue ingrowth in the first weeks after hernia repair such that permanent fixation is no longer necessary in some cases, companies introduced absorbable fixation tacks. These products, which are made from polylactic acids, show significant absorption within six months and nearly complete absorption within a year.
Although several studies have shown that absorbable tacks generally reduce postoperative pain, there are fewer data on adhesion formation using absorbable tacks. One early study of laparoscopic ventral hernia repair in a pig model found no difference in tack adhesions between metal and absorbable devices (Hernia 2004;8:358-364); in contrast, a much more recent study comparing Covidien’s metal and absorbable tacks in a rat model of laparoscopic incisional hernia repair found that adhesions were significantly reduced with absorbable tacks (Surg Endosc 2010;24:1318-1324).
Biologic Glues
Lately, hernia surgeons have eschewed point fixation altogether. The most well studied of these techniques involves fixation with resorbable biologic “glues,” most of which are tissue sealants first approved for use in thoracic or cardiovascular settings.
Much of the early research with biodegradable glues was done in inguinal hernia patients, where mesh placement within tissue planes provided a more favorable environment for glue fixation. However in the past year, three studies compared glues with other fixation methods in porcine models of laparoscopic ventral or incisional hernia repair.
The first study, conducted at the University of Southern California, found no difference in tensile strength or adhesions between four fixation methods: fibrin glue alone, transfascial sutures with tacks, fibrin glue with tacks and tacks alone (Surg Endosc 2010; July 31:Epub ahead of print).
More recently, a group at Washington University School of Medicine, in St. Louis, found that three absorbable tacking devices (PermaSorb, SorbaFix and I-Clip) were significantly stronger than fibrin glue (Surg Innov 2010;17:285-290).
Finally, in a study published in January, surgeons in Vienna demonstrated that fibrin glue fixation did not differ significantly from absorbable tacks provided that specific open-porous meshes were used. Fibrin glue did not work as well with polyester mesh coated with a resorbable collagen or condensed PTFE mesh (J Am Coll Surg 2011;212:80-86).
Covidien has introduced a self-affixing mesh that uses resorbable polylactic acid “microgrips” and adheres evenly to tissue within 60 seconds, according to the company.
“They’ve actually designed it to stick, so you’ve got these polylactic acid prongs in polypropylene, where sooner or later, the polylactic acid is resorbed and you have the underlying matrix,” said Dr. Lanzafame. “It’s the surgical equivalent of Velcro.” But currently, this mesh is not configured for laparoscopic use, he said.
Laser Tissue Welding
At the forefront of fixation is laser tissue welding or soldering, a technique that Dr. Lanzafame pioneered as a result of research funded by a National Institutes of Health (NIH) grant in collaboration with Conversion Energy Enterprises at the Laser Research Laboratory at Rochester General Hospital, in Rochester, N.Y. In this approach, mesh is welded to tissue using a collagen-based solder, which is then spread completely over the mesh material. In animal models, Dr. Lanzafame demonstrated that laser soldering can be used without increasing inflammation or adhesions compared with staples.
There are several obstacles that will need to be surmounted before surgeons can use laser-welding prosthetics intraperitoneally. “There are a couple of different issues, not the least of which is getting the [collagen-derived solder] where you want it, holding it in position and having minimal trauma to the tissue,” said Dr. Lanzafame. “This process is no small trick.”
Barrier Meshes
Even if point fixation is abandoned in favor of fibrin glues or tissue welding, surgeons still will have to deal with adhesions forming on the mesh itself, or more commonly, around the perimeter of the mesh.
The current chapter in the long-running battle to reduce adhesions began 30 years ago with the work of Scott Jenkins, MD, who performed seminal comparisons of different mesh products. In 1983, Dr. Jenkins sought to characterize adhesion formation among five different materials, most of which still are used today.
The most recent leap forward involves the creation of barrier meshes, usually comprised of a solid anti-adhesive surface bound to a standard macroporous mesh. Dr. Jenkins’ original ideal of finding a material so chemically inert that adhesions would never form is probably unrealistic, but the practical difference between placing a standard macroporous mesh and a barrier mesh intraperitoneally is the difference between bluntly dissecting thin, flimsy adhesions that are easily swept off a mesh and getting bogged down in dense, vascularized fibrotic bands that require a half-hour or longer to clear.
With the introduction of microporous mesh in the early 1980s, the market for barrier meshes exploded and at least 11 barrier meshes are being manufactured for use in the United States.
As an extension of the barrier concept, more recently liquid barrier coatings have been recommended for use in hernia repairs. Last fall, a multinational, interdisciplinary consensus conference published recommendations for adhesion prevention that included advocating use of FDA-approved adhesion barriers when appropriate.
Currently, there are three FDA-approved adhesion barriers: Seprafilm (Genzyme), Adept (Baxter) and Interceed (Gynecare), each of which has benefits and drawbacks, according to the surgeons interviewed for this article.
Seprafilm, a sodium hyaluronate/carboxymethylcellulose, was the first approved by the FDA to prevent adhesions in patients undergoing laparotomy.
“It has been shown to decrease severity of adhesions—incidence has been a little bit more questionable—and adhesion reduction seems to be what it is marketed for and what it delivers,” said Dr. Kavic.
However, in a Cochrane review of published studies, reviewers found that even though adhesions were reduced, there may have been an increased risk for leaks when Seprafilm was wrapped around anastomoses, and furthermore it did not ultimately affect rates of small bowel obstruction or morbidity and mortality.
With Seprafilm, Dr. Kavic said, “we may be preventing adhesions, but at a bit of a price.”
Less well studied are the two other adhesion barriers, Adept and Interceed.
Interceed is an oxidized, regenerated cellulose barrier approved by the FDA in 1998 for reducing adhesions in open gynecologic pelvic surgery. However, Interceed has a black box warning against use in laparoscopic surgery and is specifically contraindicated as a hemostatic agent.
“It has been shown to reduce adhesions, but it doesn’t work well when there is blood,” said Dr. Kavic. “There are very few operations that I do that involve zero blood loss; most are minimal, but there is some present.”
Finally, there is Adept, a 4% icodextrin solution approved in 2006 to reduce adhesions in patients undergoing laparoscopic gynecologic surgery. The most significant point about Adept is that it carries more contraindications than the other adhesion barriers, including infection, laparotomy incision, bowel resection, appendectomy, and uniquely, allergy to cornstarch.
Although adhesion barriers represent a step forward, by no means are they the ideal agent, said Dr. Kavic.
“We have properties of the ideal anti-adhesive—it eliminates adhesions, it’s inert, it’s cheap, it’s pliable, it’s easy to apply, but we really don’t have that agent as of yet,” he said. “Seprafilm probably comes closest to the mark for general surgery, but we do not have this for the laparoscopic setting.”
Drug Therapies: The Future?
At the farthest reaches of the adhesion prevention spectrum lie systemic or medical treatments that support normal healing while limiting adhesion formation.
Drug therapies under investigation work in one of three ways, said Dr. Rodgers, the research scientist at the University of Southern California: They reduce fibrin deposition, accelerate fibrin removal or decrease the anti-inflammatory process.
“They accelerate the healing process by reducing the inflammatory response or they reduce the scaffold that adhesions are built upon,” she said. However, many of these agents affect clotting and Dr. Rodgers said there is some risk for bleeding at a time when clotting is paramount.
Dr. Rodgers said that several other agents have shown promise, including recombinant human activated protein C, a polysaccharide similar to heparin, and a recombinant tissue plasminogen activator. But like earlier medical therapies, these agents can affect blood clotting and wound healing.
“I’ve worked with most of these kinds of drugs, and again, what I’ve noticed in my animal models when I’ve given them is there is bruising and bleeding at the incision site, and there is a very low therapeutic index between efficacy and some toxicity with their use,” Dr. Rodgers said.
The problem is that these drugs are largely systemic, rather than localized, and when they are given locally, they are diluted in a wash that’s quickly removed from the wound site.
Ultimately, Dr. Rodgers believes the future of adhesion prevention is a combination of adhesion barriers and pharmacologic therapies.
“This is where the research is going,” she said. “It’s still at very early stages, and clinically no drug yet has been shown to reduce adhesions. There are barriers that are being used clinically to prevent adhesions, and they can be effective, but they are minimally effective and they have complications. We have to find something that steps up the ability of these barriers to be effective, and my recommendation would be a drug that is safe and prevents the inflammatory events that lead to the adhesion formation.”
Currently, the general surgeon, particularly for hernia repair, has an incredible armamentarium when it to comes to preventing adhesions. Despite this, adhesions continue to proliferate.
“There is a terrific volume of research that is going into the study of preventing adhesions, but there is nothing that has really been elevated above the rest as of yet,” Dr. Kavic said.
--------------------------------------------------------------------------------
Disclosure Statements
Kathleen Rodgers, PhD, is a consultant for FzioMed and has been a consultant for Atrium Medical.
Ray Lanzafame, MD, MBA, reports grant funding from the National Institutes of Health Small Business Innovation Research (SBIR) program and research equipment from Conversion Energy Enterprises, Inc. Dr. Lanzafame also is or has been a consultant for General and Plastic Surgery Devices and other panels of the Medical Devices Advisory Committee of the FDA’s Center for Devices and Radiological Health; he has done medicolegal consulting for various law firms and entities; and he has served as a consultant for various biomedical technology companies including Carestream Health, Conversion Energy Enterprises (CEE), Eastman Kodak, Lucid, Surgicon and business and venture capital groups.
Stephen Kavic, MD, reports no disclosures and no business or financial relationships that apply to hernia fixation or to adhesion prevention.
Charles Miller, MD, reports grant/research funding from Covidien and Femasys; he has served as a consultant for Ferring Pharmaceuticals, Ethicon Endo-Surgery, Ethicon Women’s Health and Urology, Boston Scientific, Care Fusion Interlace Medical, Covidien and Femasys; he serves on the speaker’s bureau for Ferring Pharmaceuticals, Ethicon Endo-Surgery, Ethicon Women’s Health and Urology, Merck and Femasys.
http://www.generalsurgerynews.com/ViewArticle.aspx?d=In%2Bthe%2BNews&d_id=69&i=March%2B2011&i_id=711&a_id=16775
Sunday, April 03, 2011
Asherman syndrome
Uterine synechiae
Last reviewed: September 12, 2010.
Asherman syndrome is the formation of intrauterine adhesions (scar tissue), which typically develop after uterine surgery.
Causes, incidence, and risk factors
Asherman syndrome is a rare condition. In most cases, it occurs in women who have had several dilatation and curettage (D&C) procedures.
A severe pelvic infection unrelated to surgery may also lead to Asherman syndrome.
Intrauterine adhesions can also form after infection with tuberculosis or schistosomiasis. These infections are rare in the United States, and uterine complications such as Asherman syndrome related to these infections are even less common.
Symptoms
The adhesions may cause amenorrhea (lack of menstrual periods), repeated miscarriages, and infertility.
However, such symptoms could be related to several conditions. They are more likely to indicate Asherman syndrome if they occur suddenly after a D&C or other uterine surgery.
Signs and tests
A pelvic exam is usually normal.
Tests may include:
•Blood tests to detect tuberculosis or schistosomiasis
•Hysteroscopy
•Hysterosonogram
•Infertility evaluation
•Transvaginal ultrasound examination
Treatment
Treatment involves surgery to cut and remove the adhesions or scar tissue. This can usually be done with hysteroscopy, which uses small instruments and a camera placed into the uterus through the cervix.
After scar tissue is removed, the uterine cavity must be kept open while it heals to prevent adhesions from returning. Your health care provider may place a small balloon inside the uterus for several days and prescribe estrogen therapy while the uterine lining heals.
Antibiotic treatment may be necessary if there is an infection.
Support Groups
The stress of illness can often be helped by joining a support group where members share common experiences and problems. See www.ashermans.org for information about an online Asherman syndrome support group.
Expectations (prognosis)
Asherman syndrome can be cured in most women with surgery, although sometimes more than one procedure will be necessary.
Women who are infertile because of Asherman syndrome may have a successful pregnancy after treatment Successful pregnancy depends on the severity of Asherman syndrome and the difficulty of the treatment, as well as other factors that affect fertility and pregnancy.
Complications
Complications of hysteroscopic surgery are uncommon and include bleeding, perforation of the uterus, and pelvic infection.
In some cases, treatment of Asherman syndrome will not cure infertility.
Calling your health care provider
Call your health care provider if your menstrual periods do not resume after a gynecologic or obstetrical procedure. An evaluation for infertility is also warranted if you are unable to achieve a pregnancy after 6 to 12 months of trying.
Prevention
Most cases of Asherman syndrome cannot be predicted or prevented.
References
1.Lobo RA. Primary and secondary amenorrhea and precocious puberty: etiology, diagnostic evaluation, management. In: Katz VL, Lentz GM, Lobo RA, Gershenson DM, eds. Comprehensive Gynecology. 5th ed. Philadelphia, Pa: Mosby Elsevier; 2007:chap 38.
2.Simpson JL, Jauniaux ERM. Pregnancy loss. In: Gabbe SG, Niebyl JR, Simpson JL, eds. Obstetrics: Normal and Problem Pregnancies. 5th ed. Philadelphia, Pa: Elsevier Churchill Livingstone; 2007:chap 24.
Review Date: 9/12/2010.
Reviewed by: Linda J. Vorvick, MD, Medical Director, MEDEX Northwest Division of Physician Assistant Studies, University of Washington, School of Medicine; Susan Storck, MD, FACOG, Chief, Eastside Department of Obstetrics and Gynecology, Group Health Cooperative of Puget Sound, Redmond, Washington; Clinical Teaching Faculty, Department of Obstetrics and Gynecology, University of Washington School of Medicine. Also reviewed by David Zieve, MD, MHA, Medical Director, A.D.A.M., Inc.
Uterine synechiae
Last reviewed: September 12, 2010.
Asherman syndrome is the formation of intrauterine adhesions (scar tissue), which typically develop after uterine surgery.
Causes, incidence, and risk factors
Asherman syndrome is a rare condition. In most cases, it occurs in women who have had several dilatation and curettage (D&C) procedures.
A severe pelvic infection unrelated to surgery may also lead to Asherman syndrome.
Intrauterine adhesions can also form after infection with tuberculosis or schistosomiasis. These infections are rare in the United States, and uterine complications such as Asherman syndrome related to these infections are even less common.
Symptoms
The adhesions may cause amenorrhea (lack of menstrual periods), repeated miscarriages, and infertility.
However, such symptoms could be related to several conditions. They are more likely to indicate Asherman syndrome if they occur suddenly after a D&C or other uterine surgery.
Signs and tests
A pelvic exam is usually normal.
Tests may include:
•Blood tests to detect tuberculosis or schistosomiasis
•Hysteroscopy
•Hysterosonogram
•Infertility evaluation
•Transvaginal ultrasound examination
Treatment
Treatment involves surgery to cut and remove the adhesions or scar tissue. This can usually be done with hysteroscopy, which uses small instruments and a camera placed into the uterus through the cervix.
After scar tissue is removed, the uterine cavity must be kept open while it heals to prevent adhesions from returning. Your health care provider may place a small balloon inside the uterus for several days and prescribe estrogen therapy while the uterine lining heals.
Antibiotic treatment may be necessary if there is an infection.
Support Groups
The stress of illness can often be helped by joining a support group where members share common experiences and problems. See www.ashermans.org for information about an online Asherman syndrome support group.
Expectations (prognosis)
Asherman syndrome can be cured in most women with surgery, although sometimes more than one procedure will be necessary.
Women who are infertile because of Asherman syndrome may have a successful pregnancy after treatment Successful pregnancy depends on the severity of Asherman syndrome and the difficulty of the treatment, as well as other factors that affect fertility and pregnancy.
Complications
Complications of hysteroscopic surgery are uncommon and include bleeding, perforation of the uterus, and pelvic infection.
In some cases, treatment of Asherman syndrome will not cure infertility.
Calling your health care provider
Call your health care provider if your menstrual periods do not resume after a gynecologic or obstetrical procedure. An evaluation for infertility is also warranted if you are unable to achieve a pregnancy after 6 to 12 months of trying.
Prevention
Most cases of Asherman syndrome cannot be predicted or prevented.
References
1.Lobo RA. Primary and secondary amenorrhea and precocious puberty: etiology, diagnostic evaluation, management. In: Katz VL, Lentz GM, Lobo RA, Gershenson DM, eds. Comprehensive Gynecology. 5th ed. Philadelphia, Pa: Mosby Elsevier; 2007:chap 38.
2.Simpson JL, Jauniaux ERM. Pregnancy loss. In: Gabbe SG, Niebyl JR, Simpson JL, eds. Obstetrics: Normal and Problem Pregnancies. 5th ed. Philadelphia, Pa: Elsevier Churchill Livingstone; 2007:chap 24.
Review Date: 9/12/2010.
Reviewed by: Linda J. Vorvick, MD, Medical Director, MEDEX Northwest Division of Physician Assistant Studies, University of Washington, School of Medicine; Susan Storck, MD, FACOG, Chief, Eastside Department of Obstetrics and Gynecology, Group Health Cooperative of Puget Sound, Redmond, Washington; Clinical Teaching Faculty, Department of Obstetrics and Gynecology, University of Washington School of Medicine. Also reviewed by David Zieve, MD, MHA, Medical Director, A.D.A.M., Inc.
Wednesday, March 30, 2011
Drug Used For Neuropathic Pain Relieves Discomfort From Abdominal Adhesions: Henry Ford Study
Pregabalin, FDA-approved for neuropathic pain (pain caused by shingles and peripheral neuropathy), effectively reduced abdominal pain and improved sleep in women with adhesions, according to a Henry Ford study.
Adhesion pain, a common complication after abdominal or pelvic surgery, currently lacks effective therapy. Adhesions can also form after infections in the bowel such as diverticulitis.
"Many patients in the study went from debilitating pain to complete resolution of pain on pregabalin," says Ann Silverman, M.D., senior staff gastroenterologist at Henry Ford Hospital and lead author of the study.
Study results were presented at the American College of Gastroenterology's Annual Scientific Meeting in San Diego.
"Aside from the use of analgesics, additional surgery is the only treatment option for abdominal pain from adhesions but repeat surgery can lead to more adhesions," says Dr. Silverman.
The estimates of abdominal adhesion formation following surgery have been found to be as high as 100 percent in certain studies. Surgery is only recommended for bowel obstruction.
The randomized Henry Ford study looked at 18 women who received the drug or a look-alike placebo. All patients had previous abdominal surgery and were similar in age. The first eight weeks was a randomized placebo controlled trial of pregabalin followed by a four-week open label study in which all patients received the active study drug.
Click the link to read the rest.
http://www.medicalnewstoday.com/articles/168888.php
Pregabalin Side Effects
Brand Names: Lyrica
Please note - some side effects for Pregabalin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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Neuropathic Pain Medicine
Neuroveen.com/Relief-for-NeuropathyFast Acting Long-Term Neuropathic Relief. Promotes Comfort & Energy.
Side Effects of Pregabalin - for the Consumer
Pregabalin
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pregabalin:
Blurred vision; changes in sexual function; constipation; dizziness; drowsiness; dry mouth; gas; headache; increased appetite; lightheadedness; stomach pain; trouble concentrating; weight gain.
Seek medical attention right away if any of these SEVERE side effects occur when using Pregabalin:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue, unusual hoarseness); burning, numbness, or tingling of the hands, feet, or skin; chest pain; confusion; fast or irregular heartbeat; fever, chills, or persistent sore throat; inability to control urination; loss of coordination; memory loss; muscle aches, pain, tenderness, or weakness (especially if this occurs with a fever or general feeling or discomfort); new or unusual skin sores; new or worsening mental or mood changes (eg, anxiety, depression, restlessness, irritability, panic attacks, feeling "high," behavior changes, suicidal thoughts or attempts); new or worsening seizures; reddened, blistered, swollen, or peeling skin; shortness of breath or wheezing; speaking problems; sudden, unexplained weight gain; swelling of the hands, feet, or ankles; tremor; trouble sleeping; trouble walking; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Top
Side Effects by Body System - for Healthcare Professionals
Nervous system
Nervous system side effects including dizziness (up to 38%), somnolence (up to 28%), ataxia (up to 20%), tremor (up to 11%), neuropathy (up to 9%), abnormal thinking (up to 9%), abnormal gait (up to 5%), confusion (up to 7%), speech disorder (up to 7%), amnesia (up to 6%), incoordination (up to 6%), twitching (up to 5%), vertigo (up to 4%), myoclonus (up to 4%), euphoria (up to 3%), and nervousness (up to 1%) have been reported. Anxiety, depersonalization, hypertonia, hypesthesia, decreased libido, nystagmus, paresthesia, stupor, and twitching have been reported frequently. Abnormal dreams, agitation, apathy, aphasia, circumoral paresthesia, dysarthria, hallucinations, hostility, hyperalgesia, hyperesthesia, hyperkinesia, hypokinesia, hypotonia, increased libido, myoclonus, and neuralgia have been reported infrequently. Addiction, cerebellar syndrome, cogwheel rigidity, coma, delirium, delusions, dysautonomia, dyskinesia, dystonia, encephalopathy, extrapyramidal syndrome, Guillain-Barre syndrome, hypoalgesia, intracranial hypertension, manic reaction, paranoid reaction, peripheral neuritis, psychotic depression, schizophrenic reaction, torticollis, and trismus have been reported rarely.
Metabolic
Metabolic side effects including peripheral edema (up to 16%), weight gain (up to 16%), edema (up to 6%), and hypoglycemia (up to 3%) have been reported. Decreased glucose tolerance and urate crystalluria have been reported rarely.
Gastrointestinal
Gastrointestinal side effects including dry mouth (up to 15%), constipation (up to 7%), increased appetite (up to 6%), vomiting (up to 3%), flatulence (up to 3%), nausea and diarrhea have been reported. Gastroenteritis has been reported frequently. Cholecystitis, cholelithiasis, colitis, dysphagia, esophagitis, gastritis, gastrointestinal hemorrhage, melena, mouth ulceration, pancreatitis, rectal hemorrhage, and tongue edema have been reported infrequently. Aphthous stomatitis and esophageal ulcer have been reported rarely.
General
General side effects including infection (up to 14%), accidental injury (up to 11%), headache (up to 9%), asthenia (up to 7%), pain (up to 5%), chest pain (up to 4%), facial edema (up to 3%), flu syndrome (up to 2%), and back pain (up to 2%) have been reported. Abdominal pain and fever have been reported frequently. Abscess, cellulitis, chills, malaise, neck rigidity, overdose, pelvic pain, photosensitivity reaction, and suicide attempt have been reported infrequently. Ascites, granuloma, hangover effect, intentional injury, retroperitoneal fibrosis, shock, and suicide have been reported rarely.
Ocular
Ocular side effects including visual field changes (13%), reduced visual acuity (7%), and blurred vision (6%) have been reported. Conjunctivitis and diplopia have been reported frequently. Abnormality of accommodation, blepharitis, dry eyes, eye hemorrhage, hyperacusis, photophobia, retinal vascular disorder, and retinal edema have been reported infrequently. Anisocoria, blindness, corneal ulcer, exophthalmos, extraocular palsy, iritis, keratitis, keratoconjunctivitis, miosis, mydriasis, night blindness, ophthalmoplegia, optic atrophy, papilledema, parosmia, ptosis, and uveitis have been reported rarely.
Blurred vision resolved in the majority of cases with continued dosing. Less than 1% of patients discontinued pregabalin treatment due to vision related events (primarily blurred vision).
Patients should be informed that they should notify their physician if changes in vision occur. If visual disturbance persists, further assessment should be considered. Furthermore, more frequent assessment should be considered for patients who are already routinely monitored for ocular conditions.
Other
In a cohort study of 333 diabetic patients who received pregabalin for at least 2 years, the average weight gain was 5.2 kg. Pregabalin associated weight gain was related to dose and duration or exposure.
Other side effects including weight gain have been reported. In controlled clinical trials of up to 13 weeks, weight gain of 7% or more over baseline has been reported in 8% of pregabalin-treated patients. Otitis media and tinnitus have been reported frequently. Taste loss, and taste perversion have been reported infrequently.
Cardiovascular
Cardiovascular side effects including edema, primarily peripheral edema (6%) have been reported. Deep thrombophlebitis, heart failure, hypotension, syncope, and postural hypotension have been reported infrequently. Depressed ST and ventricular fibrillation have been reported rarely. There have been postmarketing reports of angioedema.
Specific symptoms of angioedema have included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There have also been reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Pregabalin should be discontinued immediately in patients with these symptoms. Caution is recommended if prescribing pregabalin to patients who have had a previous episode of angioedema. In addition, patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing angioedema.
Respiratory
Respiratory side effects including dyspnea (up to 3%) and bronchitis (up to 3%) have been reported. Apnea, atelectasis, bronchiolitis, hiccup, laryngismus, lung edema, lung fibrosis, and yawn have been reported rarely.
Genitourinary
Genitourinary side effects including urinary incontinence (up to 2%) have been reported. Anorgasmia, impotence, and urinary frequency have been reported frequently. Abnormal ejaculation, albuminuria, amenorrhea, dysmenorrhea, dysuria, hematuria, kidney calculus, leukorrhea, menorrhagia, metrorrhagia, nephritis, oliguria, and urinary retention have been reported infrequently. Acute kidney failure, balanitis, bladder neoplasm, cervicitis, dyspareunia, epididymitis, female lactation, and glomerulitis have been reported rarely. Two cases of unilateral painful gynecomastia have also been reported.
Musculoskeletal
Musculoskeletal side effects including myasthenia (1%) have been reported. Arthralgia, leg cramps, myalgia, and myasthenia have been reported frequently. Arthrosis has been reported infrequently. Generalized spasm has been reported rarely.
Oncologic
Oncologic side effects including an unexpectedly high incidence of hemangiosarcoma have been reported in animal studies after pregabalin was given their diet for two years. In clinical studies comprised of 6,396 patient-years of exposure, new or worsening-preexisting tumors were reported in 57 patients. It is not known if the incidence seen in these clinical studies is or is not affected by treatment.
Hypersensitivity
Hypersensitivity side effects including allergic reactions have been reported frequently. Allergic reactions have included skin redness, blisters, hives, rash, dyspnea, and wheezing. Pregabalin should be discontinued immediately in patients with these symptoms. Anaphylactoid reactions have been reported rarely.
Hematologic
Hematologic side effects including ecchymosis have been reported frequently. Anemia, eosinophilia, hyperchromic anemia, leukocytosis, leukopenia, lymphadenopathy, and thrombocytopenia have been reported infrequently. Myelofibrosis, polycythemia, decreased prothrombin, purpura, and thrombocytopenia have been reported rarely.
Dermatologic
Dermatologic side effects including pruritus have been reported frequently. Alopecia, dry skin, eczema, hirsutism, skin ulcer, urticaria, and vesiculobullous rash have been reported infrequently. Angioedema, exfoliative dermatitis, lichenoid dermatitis, melanosis, petechial rash, purpuric rash, pustular rash, skin atrophy, skin necrosis, skin nodule, Stevens-Johnson syndrome, and subcutaneous nodule have been reported rarely.
From Drugs.com
Adhesion pain, a common complication after abdominal or pelvic surgery, currently lacks effective therapy. Adhesions can also form after infections in the bowel such as diverticulitis.
"Many patients in the study went from debilitating pain to complete resolution of pain on pregabalin," says Ann Silverman, M.D., senior staff gastroenterologist at Henry Ford Hospital and lead author of the study.
Study results were presented at the American College of Gastroenterology's Annual Scientific Meeting in San Diego.
"Aside from the use of analgesics, additional surgery is the only treatment option for abdominal pain from adhesions but repeat surgery can lead to more adhesions," says Dr. Silverman.
The estimates of abdominal adhesion formation following surgery have been found to be as high as 100 percent in certain studies. Surgery is only recommended for bowel obstruction.
The randomized Henry Ford study looked at 18 women who received the drug or a look-alike placebo. All patients had previous abdominal surgery and were similar in age. The first eight weeks was a randomized placebo controlled trial of pregabalin followed by a four-week open label study in which all patients received the active study drug.
Click the link to read the rest.
http://www.medicalnewstoday.com/articles/168888.php
Pregabalin Side Effects
Brand Names: Lyrica
Please note - some side effects for Pregabalin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Ads by Google
Femara® HCP Information
Femara.com/HealthcareProvidersFind Patient Support Info on Femara® (letrozole) 2.5 mg tablets.
Going Cold Turkey?
TurnToHelp.comGet Info on Withdrawal, Detox, and Rehab for Painkiller Addiction
Neuropathic Pain Medicine
Neuroveen.com/Relief-for-NeuropathyFast Acting Long-Term Neuropathic Relief. Promotes Comfort & Energy.
Side Effects of Pregabalin - for the Consumer
Pregabalin
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pregabalin:
Blurred vision; changes in sexual function; constipation; dizziness; drowsiness; dry mouth; gas; headache; increased appetite; lightheadedness; stomach pain; trouble concentrating; weight gain.
Seek medical attention right away if any of these SEVERE side effects occur when using Pregabalin:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue, unusual hoarseness); burning, numbness, or tingling of the hands, feet, or skin; chest pain; confusion; fast or irregular heartbeat; fever, chills, or persistent sore throat; inability to control urination; loss of coordination; memory loss; muscle aches, pain, tenderness, or weakness (especially if this occurs with a fever or general feeling or discomfort); new or unusual skin sores; new or worsening mental or mood changes (eg, anxiety, depression, restlessness, irritability, panic attacks, feeling "high," behavior changes, suicidal thoughts or attempts); new or worsening seizures; reddened, blistered, swollen, or peeling skin; shortness of breath or wheezing; speaking problems; sudden, unexplained weight gain; swelling of the hands, feet, or ankles; tremor; trouble sleeping; trouble walking; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Top
Side Effects by Body System - for Healthcare Professionals
Nervous system
Nervous system side effects including dizziness (up to 38%), somnolence (up to 28%), ataxia (up to 20%), tremor (up to 11%), neuropathy (up to 9%), abnormal thinking (up to 9%), abnormal gait (up to 5%), confusion (up to 7%), speech disorder (up to 7%), amnesia (up to 6%), incoordination (up to 6%), twitching (up to 5%), vertigo (up to 4%), myoclonus (up to 4%), euphoria (up to 3%), and nervousness (up to 1%) have been reported. Anxiety, depersonalization, hypertonia, hypesthesia, decreased libido, nystagmus, paresthesia, stupor, and twitching have been reported frequently. Abnormal dreams, agitation, apathy, aphasia, circumoral paresthesia, dysarthria, hallucinations, hostility, hyperalgesia, hyperesthesia, hyperkinesia, hypokinesia, hypotonia, increased libido, myoclonus, and neuralgia have been reported infrequently. Addiction, cerebellar syndrome, cogwheel rigidity, coma, delirium, delusions, dysautonomia, dyskinesia, dystonia, encephalopathy, extrapyramidal syndrome, Guillain-Barre syndrome, hypoalgesia, intracranial hypertension, manic reaction, paranoid reaction, peripheral neuritis, psychotic depression, schizophrenic reaction, torticollis, and trismus have been reported rarely.
Metabolic
Metabolic side effects including peripheral edema (up to 16%), weight gain (up to 16%), edema (up to 6%), and hypoglycemia (up to 3%) have been reported. Decreased glucose tolerance and urate crystalluria have been reported rarely.
Gastrointestinal
Gastrointestinal side effects including dry mouth (up to 15%), constipation (up to 7%), increased appetite (up to 6%), vomiting (up to 3%), flatulence (up to 3%), nausea and diarrhea have been reported. Gastroenteritis has been reported frequently. Cholecystitis, cholelithiasis, colitis, dysphagia, esophagitis, gastritis, gastrointestinal hemorrhage, melena, mouth ulceration, pancreatitis, rectal hemorrhage, and tongue edema have been reported infrequently. Aphthous stomatitis and esophageal ulcer have been reported rarely.
General
General side effects including infection (up to 14%), accidental injury (up to 11%), headache (up to 9%), asthenia (up to 7%), pain (up to 5%), chest pain (up to 4%), facial edema (up to 3%), flu syndrome (up to 2%), and back pain (up to 2%) have been reported. Abdominal pain and fever have been reported frequently. Abscess, cellulitis, chills, malaise, neck rigidity, overdose, pelvic pain, photosensitivity reaction, and suicide attempt have been reported infrequently. Ascites, granuloma, hangover effect, intentional injury, retroperitoneal fibrosis, shock, and suicide have been reported rarely.
Ocular
Ocular side effects including visual field changes (13%), reduced visual acuity (7%), and blurred vision (6%) have been reported. Conjunctivitis and diplopia have been reported frequently. Abnormality of accommodation, blepharitis, dry eyes, eye hemorrhage, hyperacusis, photophobia, retinal vascular disorder, and retinal edema have been reported infrequently. Anisocoria, blindness, corneal ulcer, exophthalmos, extraocular palsy, iritis, keratitis, keratoconjunctivitis, miosis, mydriasis, night blindness, ophthalmoplegia, optic atrophy, papilledema, parosmia, ptosis, and uveitis have been reported rarely.
Blurred vision resolved in the majority of cases with continued dosing. Less than 1% of patients discontinued pregabalin treatment due to vision related events (primarily blurred vision).
Patients should be informed that they should notify their physician if changes in vision occur. If visual disturbance persists, further assessment should be considered. Furthermore, more frequent assessment should be considered for patients who are already routinely monitored for ocular conditions.
Other
In a cohort study of 333 diabetic patients who received pregabalin for at least 2 years, the average weight gain was 5.2 kg. Pregabalin associated weight gain was related to dose and duration or exposure.
Other side effects including weight gain have been reported. In controlled clinical trials of up to 13 weeks, weight gain of 7% or more over baseline has been reported in 8% of pregabalin-treated patients. Otitis media and tinnitus have been reported frequently. Taste loss, and taste perversion have been reported infrequently.
Cardiovascular
Cardiovascular side effects including edema, primarily peripheral edema (6%) have been reported. Deep thrombophlebitis, heart failure, hypotension, syncope, and postural hypotension have been reported infrequently. Depressed ST and ventricular fibrillation have been reported rarely. There have been postmarketing reports of angioedema.
Specific symptoms of angioedema have included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There have also been reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Pregabalin should be discontinued immediately in patients with these symptoms. Caution is recommended if prescribing pregabalin to patients who have had a previous episode of angioedema. In addition, patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing angioedema.
Respiratory
Respiratory side effects including dyspnea (up to 3%) and bronchitis (up to 3%) have been reported. Apnea, atelectasis, bronchiolitis, hiccup, laryngismus, lung edema, lung fibrosis, and yawn have been reported rarely.
Genitourinary
Genitourinary side effects including urinary incontinence (up to 2%) have been reported. Anorgasmia, impotence, and urinary frequency have been reported frequently. Abnormal ejaculation, albuminuria, amenorrhea, dysmenorrhea, dysuria, hematuria, kidney calculus, leukorrhea, menorrhagia, metrorrhagia, nephritis, oliguria, and urinary retention have been reported infrequently. Acute kidney failure, balanitis, bladder neoplasm, cervicitis, dyspareunia, epididymitis, female lactation, and glomerulitis have been reported rarely. Two cases of unilateral painful gynecomastia have also been reported.
Musculoskeletal
Musculoskeletal side effects including myasthenia (1%) have been reported. Arthralgia, leg cramps, myalgia, and myasthenia have been reported frequently. Arthrosis has been reported infrequently. Generalized spasm has been reported rarely.
Oncologic
Oncologic side effects including an unexpectedly high incidence of hemangiosarcoma have been reported in animal studies after pregabalin was given their diet for two years. In clinical studies comprised of 6,396 patient-years of exposure, new or worsening-preexisting tumors were reported in 57 patients. It is not known if the incidence seen in these clinical studies is or is not affected by treatment.
Hypersensitivity
Hypersensitivity side effects including allergic reactions have been reported frequently. Allergic reactions have included skin redness, blisters, hives, rash, dyspnea, and wheezing. Pregabalin should be discontinued immediately in patients with these symptoms. Anaphylactoid reactions have been reported rarely.
Hematologic
Hematologic side effects including ecchymosis have been reported frequently. Anemia, eosinophilia, hyperchromic anemia, leukocytosis, leukopenia, lymphadenopathy, and thrombocytopenia have been reported infrequently. Myelofibrosis, polycythemia, decreased prothrombin, purpura, and thrombocytopenia have been reported rarely.
Dermatologic
Dermatologic side effects including pruritus have been reported frequently. Alopecia, dry skin, eczema, hirsutism, skin ulcer, urticaria, and vesiculobullous rash have been reported infrequently. Angioedema, exfoliative dermatitis, lichenoid dermatitis, melanosis, petechial rash, purpuric rash, pustular rash, skin atrophy, skin necrosis, skin nodule, Stevens-Johnson syndrome, and subcutaneous nodule have been reported rarely.
From Drugs.com
Thursday, February 10, 2011
Peterson's Hernia after Gastric Bypass
A terrifying account of emergency adhesiolysis 10 years after a gastric bypass.
This was tricky. A middle aged lady ten years status post laparoscopic gastric bypass surgery (Roux en Y configuration) presented with crampy abdominal pain and nausea. Her plain films showed multiple dilated loops of small bowel. So I got a CT scan to better delineate the anatomy.
Bowel obstructions in Roux-n-Y gastric bypass patients always make me a little nervous. As opposed to garden variety, adhesion-mediated obstructions in people with normal anatomy, conservative treatment often fails in these patients. For one thing, you cannot adequately decompress them with nasogastric suction. Furthermore, the incidence of internal hernias is much higher, owing to the altered anatomy of the procedure (roux limbs and split mesenteries etc). So going into these cases, your threshold for surgery has to be exponentially higher than normal.
The scan above shows a subtle spiralling of some small bowel mesenteric vessels in the area where one would normally find the jejunojejunal anastomosis. Single views don't do the pathology justice; you really have to be able to scroll up and down through the loops of bowel on the scan. The patient looked uncomfortable, was tender, and I just didn't feel like dicking around for much longer. So I explored her in the OR.
She'd had two previous surgeries, prior to her gastric bypass even, for bowel obstructions secondary to an old hysterectomy, so things were pretty confusing, anatomically speaking, when I first entered her peritoneal cavity. The jejunojejunostomy appeared to be corkscrewed. That was clear enough from the beginning. Then I identified a decompressed limb of bowel going up to the gastric pouch (roux limb, a ha!). And then it looked like a bunch of small bowel had slipped through a space between the roux limb and the transverse mesocolon---classic Petersen's defect. Unfortunately, however, the bowel didn't want to slide back out of the space right away. It was stuck somewhere else further downstream. So I basically had to perform a full adhesiolysis of bowel, starting from terminal ileum and working back. To keep things organized, I literally had to place identifying stitches in the serosa of the proximal bowel as I flipped things back and forth. A couple of times it got a little hairy as the bowel started to turn bluish and I had to reverse my maneuvers, untwist things the correct way. Finally I freed everything up and the bulk of the small bowel was liberated, came rushing out from behind the defect. Looking down, the J-J anastomosis was normal again, the corkscrew configuration gone. I closed the defect, put in some voodoo-ish anti-adhesive Seprafilm and got the hell out.
Click on link to see imaging and read comments:
http://ohiosurgery.blogspot.com/2009/12/petersons-defect.html
This was tricky. A middle aged lady ten years status post laparoscopic gastric bypass surgery (Roux en Y configuration) presented with crampy abdominal pain and nausea. Her plain films showed multiple dilated loops of small bowel. So I got a CT scan to better delineate the anatomy.
Bowel obstructions in Roux-n-Y gastric bypass patients always make me a little nervous. As opposed to garden variety, adhesion-mediated obstructions in people with normal anatomy, conservative treatment often fails in these patients. For one thing, you cannot adequately decompress them with nasogastric suction. Furthermore, the incidence of internal hernias is much higher, owing to the altered anatomy of the procedure (roux limbs and split mesenteries etc). So going into these cases, your threshold for surgery has to be exponentially higher than normal.
The scan above shows a subtle spiralling of some small bowel mesenteric vessels in the area where one would normally find the jejunojejunal anastomosis. Single views don't do the pathology justice; you really have to be able to scroll up and down through the loops of bowel on the scan. The patient looked uncomfortable, was tender, and I just didn't feel like dicking around for much longer. So I explored her in the OR.
She'd had two previous surgeries, prior to her gastric bypass even, for bowel obstructions secondary to an old hysterectomy, so things were pretty confusing, anatomically speaking, when I first entered her peritoneal cavity. The jejunojejunostomy appeared to be corkscrewed. That was clear enough from the beginning. Then I identified a decompressed limb of bowel going up to the gastric pouch (roux limb, a ha!). And then it looked like a bunch of small bowel had slipped through a space between the roux limb and the transverse mesocolon---classic Petersen's defect. Unfortunately, however, the bowel didn't want to slide back out of the space right away. It was stuck somewhere else further downstream. So I basically had to perform a full adhesiolysis of bowel, starting from terminal ileum and working back. To keep things organized, I literally had to place identifying stitches in the serosa of the proximal bowel as I flipped things back and forth. A couple of times it got a little hairy as the bowel started to turn bluish and I had to reverse my maneuvers, untwist things the correct way. Finally I freed everything up and the bulk of the small bowel was liberated, came rushing out from behind the defect. Looking down, the J-J anastomosis was normal again, the corkscrew configuration gone. I closed the defect, put in some voodoo-ish anti-adhesive Seprafilm and got the hell out.
Click on link to see imaging and read comments:
http://ohiosurgery.blogspot.com/2009/12/petersons-defect.html
Monday, January 31, 2011
Adhesion Awareness: A National Survey of Surgeons.
Schreinemacher MH, ten Broek RP, et al: World J Surg; 2010;34 (December): 2805-2812
Objective: To report on a survey of Dutch surgeons, hypothesizing that lack of knowledge about adhesions and their consequences is related to surgeon practice and adhesion-related complications.
Design: Survey.
Participants: 1455 surgeons and trainees.
Methods: Initial survey questions were developed by a group of surgeons with a particular interest in adhesions. Questions were then edited by researchers with expertise in survey design and construction of multiple choice questions. Resultant survey was pilot-tested with 5 practicing surgeons and 3 surgical trainees. Final survey contained 55 multiple-choice questions, 4 open-ended questions, and 4 optional questions. Survey was sent to all members of the Dutch Association for Surgery, as well as to all registered surgical trainees. A reminder was sent electronically 1 week after the initial email if no response was obtained. Data from surveys with <80% p ="0.032).">Conclusions: The magnitude of the problem of postoperative adhesions is underestimated.
Reviewer's Comments: None of the agents that have been proposed as the magic bullet to prevent adhesions has lived up to expectations (or hopes), although certain products are effective in certain high-risk operations and populations. Even if adhesions are viewed as an inevitable result, it does make sense to include this in the preoperative discussion with patients, particularly those in high-risk groups. It appears that hopes and expectations will continue to rest on a future magic bullet.(Reviewer–Karen J. Brasel, MD, MPH).
© 2010, Oakstone Medical Publishing
Source Link
Objective: To report on a survey of Dutch surgeons, hypothesizing that lack of knowledge about adhesions and their consequences is related to surgeon practice and adhesion-related complications.
Design: Survey.
Participants: 1455 surgeons and trainees.
Methods: Initial survey questions were developed by a group of surgeons with a particular interest in adhesions. Questions were then edited by researchers with expertise in survey design and construction of multiple choice questions. Resultant survey was pilot-tested with 5 practicing surgeons and 3 surgical trainees. Final survey contained 55 multiple-choice questions, 4 open-ended questions, and 4 optional questions. Survey was sent to all members of the Dutch Association for Surgery, as well as to all registered surgical trainees. A reminder was sent electronically 1 week after the initial email if no response was obtained. Data from surveys with <80% p ="0.032).">Conclusions: The magnitude of the problem of postoperative adhesions is underestimated.
Reviewer's Comments: None of the agents that have been proposed as the magic bullet to prevent adhesions has lived up to expectations (or hopes), although certain products are effective in certain high-risk operations and populations. Even if adhesions are viewed as an inevitable result, it does make sense to include this in the preoperative discussion with patients, particularly those in high-risk groups. It appears that hopes and expectations will continue to rest on a future magic bullet.(Reviewer–Karen J. Brasel, MD, MPH).
© 2010, Oakstone Medical Publishing
Source Link
Monday, July 19, 2010
Adhesions, Adhesions-Related Disorder or CAPPS – a way to think about the problem from the patient’s perspective.
Adhesions, Adhesions-Related Disorder or CAPPS – a way to think about the problem from the patient’s perspective.
Dallas TX. June 11 2010. The International Adhesions Society (IAS) is proud to post on its adhesions.org web site the results of groundbreaking and innovative research which will forever change the way the problem of adhesions is viewed.
The paper was published after Dr. Wiseman was invited to submit a manuscript for inclusion in a special volume of “Seminars in Reproductive Medicine” on the subject of adhesions. The paper is entitled: “Disorders of Adhesions or Adhesion-Related Disorder: Monolithic Entities or Part of Something Bigger—CAPPS? “ (click here for .pdf)
Since forming the International Adhesions Society (IAS) in 1996, it became increasingly obvious that the problems of patients suffering from adhesions were not just about adhesions. Accordingly, we were the first to coin the term “Adhesion Related Disorder” (ARD) to include the entire complex of pain, infertility, obstruction, nutrition, psychological and social issues that ARD sufferers and their families experience.
Based on formal patient surveys as well as thousands of emails and phone calls from patients, it became apparent to us that even the term ARD may be inadequate to address the problem. In reality, the ARD patient is part of a much larger group of patients who, in varying degrees, combinations and sequences experience a range of symptoms and conditions including endometriosis, interstitial cystitis (IC), irritable bowel syndrome (IBS), bowel obstruction and chronic abdominal and/or pelvic pain.
Although ‘‘adhesions’’ may start out as a single, stand-alone entity, an adhesions patient may develop a number of related conditions (ARD) which renders those patients practically indistinguishable from patients with multiple symptoms originating from other abdominal or pelvic conditions. (continued)
release.
Click here for a pdf copy of the entire press
Click here for a .pdf copy of the CAPPS article
Please visit the Internation Adhesion Society to interact and become educated!
www.adhesions.org
Dallas TX. June 11 2010. The International Adhesions Society (IAS) is proud to post on its adhesions.org web site the results of groundbreaking and innovative research which will forever change the way the problem of adhesions is viewed.
The paper was published after Dr. Wiseman was invited to submit a manuscript for inclusion in a special volume of “Seminars in Reproductive Medicine” on the subject of adhesions. The paper is entitled: “Disorders of Adhesions or Adhesion-Related Disorder: Monolithic Entities or Part of Something Bigger—CAPPS? “ (click here for .pdf)
Since forming the International Adhesions Society (IAS) in 1996, it became increasingly obvious that the problems of patients suffering from adhesions were not just about adhesions. Accordingly, we were the first to coin the term “Adhesion Related Disorder” (ARD) to include the entire complex of pain, infertility, obstruction, nutrition, psychological and social issues that ARD sufferers and their families experience.
Based on formal patient surveys as well as thousands of emails and phone calls from patients, it became apparent to us that even the term ARD may be inadequate to address the problem. In reality, the ARD patient is part of a much larger group of patients who, in varying degrees, combinations and sequences experience a range of symptoms and conditions including endometriosis, interstitial cystitis (IC), irritable bowel syndrome (IBS), bowel obstruction and chronic abdominal and/or pelvic pain.
Although ‘‘adhesions’’ may start out as a single, stand-alone entity, an adhesions patient may develop a number of related conditions (ARD) which renders those patients practically indistinguishable from patients with multiple symptoms originating from other abdominal or pelvic conditions. (continued)
release.
Click here for a pdf copy of the entire press
Click here for a .pdf copy of the CAPPS article
Please visit the Internation Adhesion Society to interact and become educated!
www.adhesions.org
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