Clinical Impacts of Oral Gastrografin Follow Through in Adhesive Small Bowel Obstruction (SBO) - Full Text View

Sponsored by:	Mansoura University
Information provided by:	Mansoura University
ClinicalTrials.gov Identifier:	NCT00738855

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:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Impacts of Oral Gastrografin Follow Through in Adhesive Small Bowel Obstruction (SBO).

Resource links provided by NLM:

MedlinePlus related topics: Intestinal Obstruction

Drug Information available for: Amidotrizoic Acid Diatrizoate Diatrizoate meglumine Diatrizoate Sodium Urovision

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
1: Active Comparator Gastrografin group	Other: Oral Gastrografin 100 ml of the dye administered through a nasogastric tube
2: Placebo Comparator Control group	Other: Nothing per os A nasogastric tube

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
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

Additional Information:

Mansoura University This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Mansoura University:

Adhesions
Oral contrast
Exploration

Study placed in the following topic categories:

Intestinal Obstruction
Digestive System Diseases
Gastrointestinal Diseases
Adhesions
Intestinal Diseases

Additional relevant MeSH terms:

Intestinal Obstruction
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 11, 2009