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