Back to resultsPedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses
Primary Purpose
Peritonitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
seromuscular flap enforcement
Sponsored by
About this trial
This is an interventional prevention trial for Peritonitis
Eligibility Criteria
Inclusion Criteria:
- all patients with high risk anastomoses
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1sup group
2nd group
Arm Description
enforcement of the anastomoses with seromuscular flap
primary anastomosis without enforcement
Outcomes
Primary Outcome Measures
anastomotic leak
Secondary Outcome Measures
operative time
wound complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01391169
Brief Title
Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses
Official Title
Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a control matched prospective study evaluating the use of seromuscular flap for high risk anastomoses.
Detailed Description
30 eligible patients have been enrolled in the study then each case was matched to a control of patients who undwerwent resection anastomosis with primary anastomosis only in the same study period in terms of age, gender, comorbidity, diagnosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1sup group
Arm Type
Active Comparator
Arm Description
enforcement of the anastomoses with seromuscular flap
Arm Title
2nd group
Arm Type
Placebo Comparator
Arm Description
primary anastomosis without enforcement
Intervention Type
Other
Intervention Name(s)
seromuscular flap enforcement
Other Intervention Name(s)
primary anastomosis only
Intervention Description
seromuscular flap enforcement
Primary Outcome Measure Information:
Title
anastomotic leak
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
operative time
Time Frame
2 hours
Title
wound complications
Time Frame
5 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all patients with high risk anastomoses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ramadan ellithy, MD
Organizational Affiliation
Mansoura University
Official's Role
Study Director
Facility Information:
Facility Name
Mansoura University
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
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Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses
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