Clinical Impacts of Oral Gastrografin Follow Through in Adhesive Small Bowel Obstruction (SBO)

Not Applicable

Completed

• Conditions: Small Bowel Obstruction
• Interventions: Other: Oral Gastrografin; Other: Nothing per os

• Registration Number: NCT00738855
• Lead Sponsor: Mansoura University

Brief Summary

Mini abstract :

Altogether 100 patients with 117 episodes of ASBO were randomized into control and gastrografin groups. Eight episodes in eight patients were excluded. Gastrografin group showed a significant decrease of both the time between admission and operation and that of hospital stay .The need for surgery was reduced but statistically insignificant.

Detailed Description

Abstract

Background:

Many published studies have shown that Gastrografin can be used for diagnosis post operative acute small bowel obstruction (ASBO) and assessing the need for surgical intervention .However,the studies have reported conflicting results hence the aim of our study to test this hypothesis.

Patients and methods :

Altogether 100 patients with 117 episodes of ASBO were randomized into control and gastrografin groups in a double blinded fashion. Eight episodes in eight patients were excluded due to protocol violation. In Gastrografin group,100 ml of the dye administered through a nasogastric tube and complete obstruction has been considered if the contrast failed to reach the colon on the 24-hour film. Patients were operated on only if they developed signs of strangulation or failed to improve within 48 hours.

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2008-08
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-20
• Study First Posted: 2008-08-21
• Last Update Submitted: 2008-11-25
• Last Update Posted: 2008-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients admitted to our surgical department by postoperative SBO were considered for inclusion in this trial.

Exclusion Criteria

• Age less than 18 years
• Large bowel obstruction
• Recent (within 4 weeks) abdominal surgery
• Ileus
• Cancer peritonitis
• Peritonitis
• Strangulation symptoms and signs
• Obstructed abdominal wall or groin hernia
• Subtotal or total colectomy
• All patients in whom the final diagnosis was not SBO

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Oral Gastrografin	Gastrografin group
2	Nothing per os	Control group

Primary Outcome Measures

Name	Time	Method
resolving	48 hours

Secondary Outcome Measures

Name	Time	Method
non resolving	48 hours

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Egypt