Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT00738855
First received: August 19, 2008
Last updated: November 25, 2008
Last verified: August 2008
History of Changes
  Purpose

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.


Condition Intervention
Small Bowel Obstruction
 Other: Oral Gastrografin
Other: Nothing per os

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Impacts of Oral Gastrografin Follow Through in Adhesive Small Bowel Obstruction (SBO).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • resolving [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • non resolving [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: February 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Gastrografin group
 Other: Oral Gastrografin
100 ml of the dye administered through a nasogastric tube
Other Name: oral contrast
Placebo Comparator: 2
Control group
 Other: Nothing per os
A nasogastric tube
Other Name: no oral contrast

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738855

Locations
Egypt
Mansoura University Hospital
Mansoura, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: amir fikry, MD Mansoura university hospital
Study Director: ayman mohamed, MD mansoura university hospital
  More Information

No publications provided

Responsible Party: Amir Fikry, Mansoura University
ClinicalTrials.gov Identifier: NCT00738855     History of Changes
Other Study ID Numbers: oral gastrografin, oral, gastrografin, follow through, in, adhesive SBO.
Study First Received: August 19, 2008
Last Updated: November 25, 2008
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
Adhesions
Oral contrast
Exploration

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013