Evaluation of TAR Technique in the Treatment of Huge Abdominal Wall Hernia and Large Abdominal Wall Defect With or Without Botox Injection .

NCT ID: NCT04419844

Last Updated: 2020-06-18

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-17

Study Completion Date

2021-06-02

Brief Summary

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Aim of the work In this study, we will evaluate posterior component separation (TAR) technique with or without Botox injection for open huge ventral hernia and large abdominal wall defect repair. 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.

This prospective clinical study will be performed on 40 eligible patients admitted to general surgery department at Mansoura University Hospi

Detailed Description

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Conditions

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TAR Technique

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAR with Botox

Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect Botox injection .

Group Type ACTIVE_COMPARATOR

Tar with Botox

Intervention Type PROCEDURE

Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect with Botox injection .

TAR without Botox

Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect without Botox injection .

Group Type ACTIVE_COMPARATOR

Tar with Botox

Intervention Type PROCEDURE

Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect with Botox injection .

Interventions

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Tar with Botox

Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect with Botox injection .

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult patient fit for general anesthesia with huge ventral hernia (primary, incisional or recurrent).Any patient with large abdominal wall defect secondary to abdominal wall tumor excision or burst after surgery

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. Patients who refuse to participate in our study.
Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Arnouse

Role: CONTACT

01099222561

Facility Contacts

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Mohamed Hamada Mohamed Hamada

Role: primary

+20 109 212 7930

Other Identifiers

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R.19.03.451 - 2019/03/11

Identifier Type: -

Identifier Source: org_study_id

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