Evaluation of Posterior Component Separation Technique in the Management of Complex Ventral Hernia.

April 2, 2024 updated by: Mohamed Mahmoud Mohamed Yehya, Assiut University

Posterior Component Separation in the Management of the Complex Ventral Hernia

  • Assess short term outcome of posterior component separation technique(PCS) including the regain of the physiological function of the abdominal wall.
  • Detect most common post operative complications related to AWR techniques in a 6 months duration after operation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

posterior component separation(PCS) is one of the surgical techniques used in abdominal wall reconstruction plan foe management of relatively complex ventral hernia ,which cannot be treated with the conventional surgical way.

With or without transverses abdominis release(TAR) technique, (PCS) became widely accepted as surgical technique specially for large sized hernia defect, previous multiple laparotomies or unhealth abdominal soft tissue.

This study has a primary outcome which is detection of recurrence rate in patients under went posterior component separation technique in a period of 6 month after operation.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with complex ventral hernia with contraindication to the conventional surgical therapy.

Exclusion Criteria:

  1. patients with contraindication to long standing anesthesia.
  2. patients with emergency hernia situation.
  3. pregnant patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PCS with TAR
The posterior component separation technique utilizes the retro-rectus space, accessed by incising the posterior rectus sheath and dissecting the posterior sheath between the internal oblique and transversus abdominis muscle.
Procedure: Posterior component separation technique.
By dividing the posterior rectus sheath, a posterior plane is reached which can be advanced by dividing the transversus abdominis muscle with reinforcement of the midline with synthetic mesh.
Active Comparator: PCS without TAR
by performing posterior component separation technique through inscion in the posterior rectus sheath and mesh placement in this plane without performing more advancement towards tranversus abdominis muscle.
Procedure: Posterior component separation technique.
By dividing the posterior rectus sheath, a posterior plane is reached which can be advanced by dividing the transversus abdominis muscle with reinforcement of the midline with synthetic mesh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hernia recurrence
Time Frame: six month after operation
develop ventral hernia recurrence
six month after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative short term complications
Time Frame: One month after operation
wound infection(hematoma, seroma) and wound dehiscence
One month after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Samir A Ammar, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Posterior component separation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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