Back to resultsEvaluation 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
About this trial
This is an interventional treatment trial for TAR Technique
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.
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
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 .
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