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Status unknownNCT04419844Updated Jun 18, 2020

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

An interventional study of Tar with Botox in TAR Technique, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-06-18.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
12 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • TAR Technique
03

Who can participate

Ages eligible
12 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    TAR with Botox

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

    Procedure: Tar with Botox

  • Active comparator
    TAR without Botox

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

    Procedure: Tar with Botox

Interventions

  • ProcedureTar with Botox

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

05

What researchers measure

Primary outcomes

  1. Recurrence

    Recurrence of the ventral hernia

    Time frame: one year

06

Study locations

1 of 1 sites recruiting
  • Mansoura University
    Mansoura, Dakahlia, Egypt
    Recruiting
07

Registry details

Key details

Study ID
NCT04419844
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
Jun 5, 2020
Start date
Jun 17, 2020
Primary completion
Jun 1, 2021 (estimated)
Completion
Jun 2, 2021 (estimated)
Last update
Jun 18, 2020

Study contacts

Mohamed Arnouse
Contact
drmhamdy@mans.edu.eg
01099222561

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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