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

Small Bowel Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738855
• Other study ID #: oral gastrografin
• Secondary ID: oralgastrografin
• Status: Completed
• Phase: N/A
• First received: August 19, 2008
• Last updated: November 25, 2008
• Start date: February 2006
• Est. completion date: January 2008

Study information

• Verified date: August 2008
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Obstruction

Intervention

Other:
• Oral Gastrografin
100 ml of the dye administered through a nasogastric tube
• Nothing per os
A nasogastric tube

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resolving		48 hours	Yes
Secondary	non resolving		48 hours	Yes