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

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ClinicalTrials.gov Identifier: NCT00738855
Recruitment Status : Completed
First Posted : August 21, 2008
Last Update Posted : November 26, 2008
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Small Bowel Obstruction Other: Oral Gastrografin Other: Nothing per os Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Impacts of Oral Gastrografin Follow Through in Adhesive Small Bowel Obstruction (SBO).
Study Start Date : February 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. resolving [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. non resolving [ Time Frame: 48 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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.
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: November 26, 2008
Last Verified: August 2008

Keywords provided by Mansoura University:
Adhesions
Oral contrast
Exploration

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