search
Back to results

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

Primary Purpose

TAR Technique

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tar with Botox
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TAR Technique

Eligibility Criteria

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

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.

Sites / Locations

  • Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TAR with Botox

TAR without Botox

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recurrence
Recurrence of the ventral hernia

Secondary Outcome Measures

Full Information

First Posted
June 3, 2020
Last Updated
June 17, 2020
Sponsor
Mansoura University
search

1. Study Identification

Unique Protocol Identification Number
NCT04419844
Brief Title
Evaluation of TAR Technique in the Treatment of Huge Abdominal Wall Hernia and Large Abdominal Wall Defect With or Without Botox Injection .
Official Title
Evaluation of TAR Technique in the Treatment of Huge Abdominal Wall Hernia and Large Abdominal Wall Defect With or Without Botox Injection .
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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAR with Botox
Arm Type
Active Comparator
Arm Description
Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect Botox injection .
Arm Title
TAR without Botox
Arm Type
Active Comparator
Arm Description
Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect without Botox injection .
Intervention Type
Procedure
Intervention Name(s)
Tar with Botox
Intervention Description
Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect with Botox injection .
Primary Outcome Measure Information:
Title
Recurrence
Description
Recurrence of the ventral hernia
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Arnouse
Phone
01099222561
Email
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
Email
irb.mfm@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs