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

Primary Purpose

TAR Technique

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

posterior component separation modified TAR technique "Transversus Abdominids Release"

About this trial

This is an interventional treatment trial for TAR Technique

Eligibility Criteria

10 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mansoura UniversityRecruiting

Outcomes

Primary Outcome Measures

Recurrence rate

Recurrence rate of parastomal hernias

Secondary Outcome Measures

Full Information

NCT ID

NCT04418349

First Posted

June 3, 2020

Last Updated

June 17, 2020

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT04418349

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 17, 2020 (Actual)

Primary Completion Date

June 1, 2021 (Anticipated)

Study Completion Date

June 2, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

TAR Technique

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

posterior component separation modified TAR technique "Transversus Abdominids Release"

Intervention Description

Evaluation of posterior component separation modified TAR technique "Transversus Abdominids Release" in the treatment of parastomal hernia

Primary Outcome Measure Information:

Title

Recurrence rate

Description

Recurrence rate of parastomal hernias

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed Arnouse

Phone

01099222561

drmhamdy@mans.edu.eg

Facility Information:

Facility Name

Mansoura University

City

Mansoura

State/Province

Dakahlia

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohamed Hamada Mohamed Hamada

Phone

+20 109 212 7930

irb.mfm@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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