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

Condition(s) targeted: Small Bowel Obstruction

Intervention: gastrograffin (Drug); water (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Rouen

Official(s) and/or principal investigator(s):
michel scotté, MD,PhD, Principal Investigator, Affiliation: CHU Rouen
francois mauvais, MD, Study Director, Affiliation: chg Beauvais
jean-marc regimbeau, MD, PhD, Study Director, Affiliation: CHU amiens

Overall contact:
michel scotte, MD,PhD, Phone: 33232888142, Email: michel.scotte@chu-rouen.fr

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

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

Study design: Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment

Primary outcome: Need for surgical management

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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

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

CHU, ROUEN 76000, France; Recruiting
michel scotte, Principal Investigator
michel scotte, md, phd, Principal Investigator

Starting date: November 2006
Last updated: August 28, 2008