Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses

Not Applicable

Completed

• Conditions: Peritonitis
• Interventions: Other: seromuscular flap enforcement

• Registration Number: NCT01391169
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Status Verified: 2009-04
• Study Start: 2009-04
• Primary Completion: 2011-04
• Study Completion: 2011-06
• Study First Submitted: 2011-07-06
• Study First Submitted QC: 2011-07-08
• Last Update Submitted: 2011-07-08
• Study First Posted: 2011-07-11
• Last Update Posted: 2011-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• all patients with high risk anastomoses

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1sup group	seromuscular flap enforcement	enforcement of the anastomoses with seromuscular flap
2nd group	seromuscular flap enforcement	primary anastomosis without enforcement

Primary Outcome Measures

Name	Time	Method
anastomotic leak	5 weeks

Secondary Outcome Measures

Name	Time	Method
operative time	2 hours
wound complications	5 weeks

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt