Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04419844
Other study ID # R.19.03.451 - 2019/03/11
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 17, 2020
Est. completion date June 2, 2021

Study information

Verified date May 2020
Source Mansoura University
Contact Mohamed Arnouse
Phone 01099222561
Email drmhamdy@mans.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 2, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Mansoura University Mansoura Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence Recurrence of the ventral hernia one year
See also
  Status Clinical Trial Phase
Recruiting NCT04418349 - Evaluation of Posterior Component Separation Modified TAR Technique "Transversus Abdominids Release" in the Treatment of Parastomal Hernia N/A