Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses

NCT ID: NCT01391169

Last Updated: 2011-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Peritonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1sup group

enforcement of the anastomoses with seromuscular flap

Group Type ACTIVE_COMPARATOR

seromuscular flap enforcement

Intervention Type OTHER

seromuscular flap enforcement

2nd group

primary anastomosis without enforcement

Group Type PLACEBO_COMPARATOR

seromuscular flap enforcement

Intervention Type OTHER

seromuscular flap enforcement

Interventions

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seromuscular flap enforcement

seromuscular flap enforcement

Intervention Type OTHER

Other Intervention Names

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primary anastomosis only

Eligibility Criteria

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Inclusion Criteria

* all patients with high risk anastomoses
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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mansoura university

Principal Investigators

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ramadan ellithy, MD

Role: STUDY_DIRECTOR

Mansoura University

Locations

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Mansoura University

Al Mansurah, Mansoura, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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seromuscular flap

Identifier Type: -

Identifier Source: org_study_id

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