Evaluation of Posterior Component Separation Modified TAR Technique "Transversus Abdominids Release" in the Treatment of Parastomal Hernia

June 17, 2020 updated by: Mansoura University
Aim of the work In this study, we will evaluate posterior Evaluation of posterior component separation modified TAR technique "Transversus Abdominids Release" in the treatment of parastomal hernia. The primary outcome will be recurrence while the secondary outcome will be infection, postoperative complications (bleeding and dehiscence), pain score, operative time, hospitalization, need for drain, time for drain removal and pulmonary function test before and after surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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
    • Dakahlia
      • Mansoura, Dakahlia, Egypt
        • Recruiting
        • 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

10 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patient fit for general anesthesia with parastomal herniation.

Exclusion Criteria:

  • Patients who are unfit for general anaesthesia.
  • Poor pulmonary function tests.
  • Pregnant females.
  • Patient younger than 18 years.
  • Immunodeficiency.
  • Patient with psychiatric disease disabling surgical intervention.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate
Time Frame: one year
Recurrence rate of parastomal hernias
one year

Collaborators and Investigators

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

Sponsor

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 (Actual)

June 17, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 2, 2021

Study Registration Dates

First Submitted

June 3, 2020

First Submitted That Met QC Criteria

June 4, 2020

First Posted (Actual)

June 5, 2020

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R.19.07.563 - 2019/07/15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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