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

Small Bowel Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389116
• Other study ID #: 2005/069/HP
• Status: Completed
• Phase: Phase 4
• First received: October 17, 2006
• Last updated: February 24, 2011
• Start date: November 2006
• Est. completion date: August 2010

Study information

• Verified date: February 2011
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: August 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Obstruction

Intervention

Drug:
• gastrograffin
ingestion
• water
oral water ingestion

Locations

Country	Name	City	State
France	CHU	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for surgical management		2 months	Yes
Secondary	Sensibility and specificity of gastrografin oral administration		2 months	Yes
Secondary	Sensibility and specificity of CT-Scan.		2 months	Yes
Secondary	Sensibility and specificity of abdominal X-ray.		2 months	Yes
Secondary	Fasting time		2 months	Yes
Secondary	Hospitalization time		2 months	Yes
Secondary	Number of small bowel resection		2 months	Yes