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NCT01391169 Clinical Trial

Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses

Peritonitis Clinical Trial

Official title:
Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01391169
Other study ID # seromuscular flap
Secondary ID
Status Completed
Phase N/A
First received July 6, 2011
Last updated July 8, 2011
Start date April 2009
Est. completion date June 2011

Study information
Verified date April 2009
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Health and Population
Study type Interventional

Clinical Trial Summary

This is a control matched prospective study evaluating the use of seromuscular flap for high risk anastomoses.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date June 2011
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- all patients with high risk anastomoses

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• seromuscular flap enforcement
seromuscular flap enforcement

Locations
Country Name City State
Egypt Mansoura University Mansoura

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary anastomotic leak 5 weeks Yes
Secondary operative time 2 hours Yes
Secondary wound complications 5 weeks Yes
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