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

NCT ID: NCT00389116

Last Updated: 2011-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2010-08-31

Brief Summary

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

Conditions

Small Bowel Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Group Type: EXPERIMENTAL

gastrograffin

Intervention Type: DRUG

ingestion

2

Group Type: PLACEBO_COMPARATOR

water

Intervention Type: DRUG

oral water ingestion

Interventions

gastrograffin

ingestion

Intervention Type: DRUG

water

oral water ingestion

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

CHU Rouen

Principal Investigators

michel scotté, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

francois mauvais, MD

Role: STUDY_DIRECTOR

chg Beauvais

jean-marc regimbeau, MD, PhD

Role: STUDY_DIRECTOR

CHU amiens

Locations

CHU

Rouen, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 23522439 (View on PubMed)

Other Identifiers

2005/069/HP

Identifier Type: -

Identifier Source: org_study_id