search
Back to results

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

Primary Purpose

Small Bowel Obstruction

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Oral Gastrografin
Nothing per os
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Bowel Obstruction focused on measuring Adhesions, Oral contrast, Exploration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mansoura University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Gastrografin group

Control group

Outcomes

Primary Outcome Measures

resolving

Secondary Outcome Measures

non resolving

Full Information

First Posted
August 19, 2008
Last Updated
November 25, 2008
Sponsor
Mansoura University
search

1. Study Identification

Unique Protocol Identification Number
NCT00738855
Brief Title
Clinical Impacts of Oral Gastrografin Follow Through in Adhesive Small Bowel Obstruction (SBO)
Official Title
Clinical Impacts of Oral Gastrografin Follow Through in Adhesive Small Bowel Obstruction (SBO).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Obstruction
Keywords
Adhesions, Oral contrast, Exploration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Gastrografin group
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
Oral Gastrografin
Other Intervention Name(s)
oral contrast
Intervention Description
100 ml of the dye administered through a nasogastric tube
Intervention Type
Other
Intervention Name(s)
Nothing per os
Other Intervention Name(s)
no oral contrast
Intervention Description
A nasogastric tube
Primary Outcome Measure Information:
Title
resolving
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
non resolving
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
amir fikry, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ayman mohamed, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Mansoura University Hospital
City
Mansoura
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs