Thursday, February 24, 2011

Hyperosmolar water-soluble contrast medium in the management of adhesive small-intestine obstruction.

J Int Med Res. 2010;38(6):2126-34.

Hyperosmolar water-soluble contrast medium in the management of adhesive small-intestine obstruction.
Atahan K, Aladağli I, Cökmez A, Gür S, Tarcan E.

First Surgical Department, İzmir Atatürk Training and Research Hospital, İzmir, Turkey.

This prospective study investigated the value of the hyperosmolar water-soluble contrast medium Urografin(®) in choosing which patients with small-intestine obstruction, caused by post-operative adhesions, to treat conservatively. Thirty-seven patients with adhesive intestinal obstruction received Urografin(®) via a nasogastric tube. Direct abdominal radiographs were taken after 2, 4 and 8 h. Twenty-four patients (64.9%) had Urografin(®) in the right colon within 8 h and were considered to have partial obstruction. These patients commenced oral feeding even though abdominal radiographs revealed gas-fluid levels. In the remaining 13 patients (35.1%), Urografin(®) was not observed in the right colon within 8 h: three of the 13 patients (23.1%) were successfully treated conservatively; 10 of the 13 patients (76.9%) developed toxic signs and underwent surgery, with obstruction resulting from adhesive bands being confirmed at operation. Conservative treatment can be recommended for patients in whom contrast medium is observed in the right colon within 8 h following administration, regardless of the presence of obstruction signs. Absence of contrast medium in the right colon within 8 h cannot, however, be considered an indication for surgery.

PMID: 21227018 [PubMed - in process]

Wednesday, February 16, 2011

Mom Dies of Adhesion Related Disorder


OMAHA, Neb. -- Employees at a local Red Robin restaurant helped an 8-year-old boy deal with the loss of his mother.

Austin Leeling's family said his mother, Robin, died Friday from a little known condition called Adhesion-Related Disorder.

Because his mother's name was Robin, he said he decided to eat at the Red Robin restaurant on 180th Street......

Click Link to see video

Friday, February 11, 2011

FDA Mulls Health Warning on Powdered Gloves

By John Gever, Senior Editor, MedPage Today
Published: February 08, 2011

Health risks associated with powdered medical gloves -- for professionals as well as patients -- may soon be highlighted on their packages, according to the FDA.

In a draft guidance document for manufacturers, the FDA proposed that powdered surgical and patient examination gloves carry a warning that the products may cause health problems ranging from latex allergies to granulomas and adhesions in patients.

The guidance won't be formally adopted until after the agency digests comments on the proposal, which it is accepting through April. Technically, guidance documents are not enforceable, but most manufacturers follow their recommendations scrupulously.

According to the draft, the FDA is reacting to reports on adverse effects associated with powdered medical gloves.

In 1997, an FDA study found a range of allergic reactions that could be caused by these products, which include gloves made of natural rubber latex, nitrile, vinyl, and polychloroprene.

The powder particles -- usually cornstarch -- can carry latex molecules from the natural rubber gloves, triggering or exacerbating allergies in some patients and professionals, the FDA found.

Powders on nonlatex gloves have also been the subject of adverse event reports more recently, the FDA indicated, citing more than 30 studies. These include impaired wound healing, inflammation, granulomas, and adhesions in patients.

Some have shown that hospitals switching to unpowdered gloves have reduced allergy development and respiratory problems, the FDA added.

The agency also noted, however, that "this has not been a universal finding," and the studies have had significant methodological limitations.

Nevertheless, the agency is proposing that manufacturers include the following warning on glove boxes:

"Powdered gloves may lead to foreign body reactions and the formation of granulomas in patients. In addition, the powder used on gloves may contribute to the development of irritant dermatitis and Type IV allergy, and on latex gloves may serve as a carrier for airborne natural latex leading to sensitization of glove users."

If the guidance is adopted, manufacturers are urged to place the warning on product labeling within six months.

Bologna Guidelines for Diagnosis and Management of Adhesive Small Bowel Obstruction

(ASBO): 2010 Evidence-Based Guidelines of the World Society of Emergency Surgery

There is no consensus on diagnosis and management of ASBO. Initial conservative management is usually safe, however proper timing for discontinuing non operative treatment is still controversial.

Open surgery or laparoscopy are used without standardized indications.

Methods: A panel of 13 international experts with interest and background in ASBO and peritoneal diseases, participated in a consensus conference during the 1st International Congress of the World Society of Emergency Surgery and 9th Peritoneum and Surgery Society meeting, in Bologna, July 1-3, 2010, for developing evidence-based recommendations for diagnosis and management of ASBO. Whenever was a lack of high-level evidence, the working group formulated guidelines by obtaining consensus.Recommendations: In absence of signs of strangulation and history of persistent vomiting or combined CT scan signs (free fluid, mesenteric oedema, small bowel faeces sign, vascularisedbowel) patients with partial ASBO can be managed safely with NOM and tube decompression (either with long or NG) should be attempted.

These patients are good candidates for Water Soluble Contrast Medium (WSCM) with both diagnostic and therapeutic purposes. The appearance of water-soluble contrast in the colon on X-ray within 24 hours from administration predicts resolution.

WSCM may be administered either orally or via NGT (50-150 ml) both immediately at admission or after an initial attempt of conservative treatment of 48 hours. The use of WSCM for ASBO is safe and reduces need for surgery, time to resolution and hospital stay.NOM, in absence of signs of strangulation or peritonitis, can be prolonged up to 72 hours.

After 72 hours of NOM without resolution surgery is recommended.Patients treated non-operatively have shorter hospital stay, but higher recurrence rate and shorter time to re-admission, although the risk of new surgically treated episodes of ASBO is unchanged. Risk factors for recurrences are age <40 years and matted adhesions.

WSCM does not affect recurrence rates or recurrences needing surgery when compared to traditional conservative treatment.Open surgery is the preferred method for surgical treatment of strangulating ASBO as well as after failed conservative management. In highly selected patients and with appropriate skills, laparoscopic approach can be attempted using open access technique.

Access in the left upper quadrant should be safe. Laparoscopic adhesiolysis should be attempted preferably in case of first episode of SBO and/or anticipated single band.

A low threshold for open conversion should be maintained.Peritoneal adhesions should be prevented. Hyaluronic acid-carboxycellulose membrane and icodextrin can reduce incidence of adhesions.

Icodextrin may reduce the risk of re-obstruction. HA cannot reduce need of surgery.

Author: Fausto CatenaSalomone Di SaverioMichael KellyWalter BifflLuca AnsaloniVincenzo MandalaGeorge VelmahosMassimo SartelliGregorio TugnoliMassimo LupoStefano MandalaAntonio PinnaPaul SugarbakerHarry Van GoorErnest MooreJohannes Jeekel

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:

Monday, February 07, 2011

A Device Preemption Quickie -- Heisner v. Genzyme

In Heisner v. Genzyme, No. 08-C-593, 2009 U.S. Dist. LEXIS 37322 (N.D. Ill. Apr. 30, 2009), Heisner allegedly died as a result of an allergic reaction to Seprafilm, an anti-adhesive surgical barrier implanted in her body during a surgery. Seprafilm is a Class III medical device approved by the FDA through the premarket approval process.

Heisner's surviving spouse and estate filed the usual product liability claims against Genzyme, which manufactured Seprafilm. The trial court granted Genzyme's motion to dismiss on the ground of federal preemption.

Two items merit quick note: First, plaintiff asserted that his claims were "parallel" to, rather than "different from or in addition to" the federal requirements applicable to Seprafilm, because Genzyme had allegedly failed to report to the FDA (1) the death of plaintiff's decedent, and (2) a clinical trial protocol and related warnings finalized after Heisner's death. The trial court didn't have to address the "parallel requirements" issue, because events that took place after Heisner's death could not possibly have proximately caused Heisner's injury. Id. at *5.

Second, plaintiff's express warranty claims were based on statements made by Genzyme in (1) the package inserts for Seprafilm, and (2) the PMA protocol for certain Seprafilm clinical trials -- both of which had been approved by the FDA. Because the alleged warranties were based on statements that had been approved by the FDA, the court found those allegations of breach of warranty to be preempted. Id. at *8.

We'll include this one in the ever-expanding (New) Medical Device Preemption Scorecard.
Posted by Beck/Herrmann at 8:00 AM Labels: Medical Device, Preemption