Anterior Component Separation Versus Posterior Component Separation for Repair of Large Ventral Hernias

October 18, 2022 updated by: Zaza Demetrashvili

Anterior Component Separation Versus Posterior Component Separation for Repair of Large Ventral Hernias: a Prospective Cohort Study

This study evaluates effect of anterior component separation and posterior component separation and transversus abdominis muscle release methods for treatment of midline ventral hernias.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The anterior component separation technique requires an extensive subcutaneous flap elevation, incision of the external oblique aponeurosis, and incision of the posterior rectus sheath.

The posterior component separation technique utilized the retromuscular space, accessed by incising the posterior rectus sheath and dissecting the posterior sheath between the internal oblique and transversus abdominis muscles. Transversus abdominis muscle release dissected the posterior sheath back to the transversus abdominal muscle and accessed the space between muscle and trasversalis fascia.

Study Type

Interventional

Enrollment (Anticipated)

40

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

  • Name: Zaza Demetrashvili, MD, PhD
  • Phone Number: +995599217733
  • Email: zdemetr@yahoo.com

Study Contact Backup

Study Locations

  • Georgia
      • Tbilisi, Georgia, 0186
        • Recruiting
        • Tbilisi State Medical University
        • Contact:
        • Principal Investigator:
          • Zaza Demetrashvili

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subject has midline ventral hernia
  • patient's approval to participate in the study

Exclusion Criteria:

  • strangulated hernia
  • patient's preference for either operative technique
  • patient's refusal to participate in the study

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: anterior component separation
The anterior component separation technique requires an extensive subcutaneous flap elevation, incision of the external oblique aponeurosis, and incision of the posterior rectus sheath.
Procedure: Anterior component separation
Active Comparator: posterior component separation
The posterior component separation technique utilized the retromuscular space, accessed by incising the posterior rectus sheath and dissecting the posterior sheath between the internal oblique and transversus abdominis muscles.
Procedure: Posterior component separation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hernia recurrence
Time Frame: during 3 year after surgery
Develop of ventral hernia recurrence
during 3 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound complications
Time Frame: 30 day after surgery
Develop of wound complications (seroma, hematoma, surgical site infection)
30 day after surgery

Collaborators and Investigators

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

Sponsor

Zaza Demetrashvili

Investigators

  • Principal Investigator: Zaza Demetrashvili, PhD, Tbilisi State Medical University

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 (Actual)

December 1, 2016

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

December 27, 2018

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01004006344

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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