Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses

July 8, 2011 updated by: Mansoura University
This is a control matched prospective study evaluating the use of seromuscular flap for high risk anastomoses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients with high risk anastomoses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1sup group
enforcement of the anastomoses with seromuscular flap
Other: seromuscular flap enforcement
seromuscular flap enforcement
Other Names:
  • primary anastomosis only
Placebo Comparator: 2nd group
primary anastomosis without enforcement
Other: seromuscular flap enforcement
seromuscular flap enforcement
Other Names:
  • primary anastomosis only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
anastomotic leak
Time Frame: 5 weeks
5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
operative time
Time Frame: 2 hours
2 hours
wound complications
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Director: ramadan ellithy, MD, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

July 6, 2011

First Submitted That Met QC Criteria

July 8, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Estimate)

July 11, 2011

Last Update Submitted That Met QC Criteria

July 8, 2011

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • seromuscular flap

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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