Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction / Clinical Trial

SOURCE: clinicaltrials.gov

Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction

This study is not yet open for patient recruitment.
Verified by University Hospital of Rouen October 2006

Sponsored by: University Hospital of Rouen
Information provided by: University Hospital of Rouen
ClinicalTrials.gov Identifier: NCT00389116


Purpose

Small bowel obstructions are responsible for 2 to 5% of emergency hospital admissions and 20% of all emergency surgical procedures. In 60 to 80% of cases, acute small bowel obstructions are the consequence of intraperitoneal postoperative adhesions. They constitute an extremely frequent pathology, leading to a high rate of hospital admissions and money expense.

Management of small bowel obstruction is based on 2 options: either a surgical approach where all patients are operating on, or a conservative treatment in which surgery is proposed in case of failure of medical treatment. The surgical approach leads to operate on an excessive rate of patients while the medical approach increases the risk of increased small bowel resection, morbidity rate or hospitalization duration.

In order to improve the management of small bowel obstruction, it seems necessary to better distinguish patients that need an emergency surgical procedure from patients in which medical treatment will be useful. Many studies have been performed to investigate the value of imaging in the management of small bowel obstruction, using abdominal X-ray, oral gastrografin administration or CT-Scan.

The aim of this study is to analyse the effect of a systematic performance of imaging investigation on the management of patients presenting with a postoperative small bowel obstruction.

All patients suffering from a postoperative small bowel obstruction will be included in this study. They will be randomised in 2 groups. In group S, patients will have CT-Scan and oral water administration while in group SG, Patients will have CT-Scan and oral gastrografin administration The major end point of this study is to analyse whether imaging examination can reduce the need for a surgical approach or the rate of small bowel resection and to determine its influence on fasting time or hospitalization duration

Condition Intervention Phase
Small Bowel Obstruction
Procedure: oral gastrografin
Phase IV


MedlinePlus related topics: Digestive Diseases


Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment

Official Title: Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction

Further study details as provided by University Hospital of Rouen:
Primary Outcomes: Need for surgical management
Secondary Outcomes: Sensibility and specificity of gastrografin oral administration; Sensibility and specificity of CT-Scan.; Sensibility and specificity of abdominal X-ray.; Fasting time; Hospitalization time; Number of small bowel resection
Expected Total Enrollment: 242

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:

Small bowel obstruction in patients with previous abdominal surgery
Exclusion Criteria:

Age less than 18 years
Early small bowel obstruction (less than 4 weeks following abdominal surgery)
Small bowel obstruction in the course of digestive cancer.
Hyperthermic small bowel obstruction
Small bowel ischemia (fever, peritoneal signs, increased leucocytosis)
Pregnancy ( Elevated béta HCG levels)
Inflammatory bowel disease
Previous abdominal radiotherapy
Pneumoperitoneum
Colorectal obstruction
Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00389116

michel scotte, MD,PhD 33232888142 michel.scotte@chu-rouen.fr



Study chairs or principal investigators

michel scotté, MD,PhD, Principal Investigator, CHU Rouen
francois mauvais, MD, Study Director, chg Beauvais
jean-marc regimbeau, MD, PhD, Study Director, CHU amiens
More Information

Study ID Numbers: 2005/069/HP
Last Updated: October 17, 2006
Record first received: October 17, 2006
ClinicalTrials.gov Identifier: NCT00389116
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2006-10-28