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

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

Study Overview

• Status: Completed
• Conditions: Small Bowel Obstruction
• Intervention / Treatment: Drug: gastrograffin; Drug: water

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76000
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2	Drug: water; oral water ingestion
EXPERIMENTAL: 1	Drug: gastrograffin; ingestion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Need for surgical management	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Sensibility and specificity of gastrografin oral administration	2 months
Sensibility and specificity of CT-Scan.	2 months
Sensibility and specificity of abdominal X-ray.	2 months
Fasting time	2 months
Hospitalization time	2 months
Number of small bowel resection	2 months

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: michel scotté, MD,PhD, CHU Rouen; Study Director: francois mauvais, MD, chg Beauvais; Study Director: jean-marc regimbeau, MD, PhD, CHU Amiens

Publications and helpful links

General Publications

• Cosse C, Regimbeau JM, Fuks D, Mauvais F, Scotte M. Serum procalcitonin for predicting the failure of conservative management and the need for bowel resection in patients with small bowel obstruction. J Am Coll Surg. 2013 May;216(5):997-1004. doi: 10.1016/j.jamcollsurg.2012.12.051. Epub 2013 Mar 19.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (ACTUAL): August 1, 2009
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: October 17, 2006
• First Submitted That Met QC Criteria: October 17, 2006
• First Posted (ESTIMATE): October 18, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): February 25, 2011
• Last Update Submitted That Met QC Criteria: February 24, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: 2005/069/HP