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

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: Large Midline Ventral Hernia
• Intervention / Treatment: Procedure: Anterior component separation; Procedure: Posterior component separation

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

• Study Contact: Name: Zaza Demetrashvili, MD, PhD; Phone Number: +995599217733; Email: zdemetr@yahoo.com
• Study Contact Backup: Name: George Kenchadze, MD; Phone Number: +995599351249; Email: gugaken@yahoo.com

Study Locations

• Georgia
  • Tbilisi, Georgia, 0186
    • Recruiting
    • Tbilisi State Medical University
    • Contact: Zaza Demetrashvili; Email: zdemetr@yahoo.com
    • Principal Investigator: Zaza Demetrashvili

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Develop of ventral hernia recurrence	during 3 year after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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: anterior component separation, TAR
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: 01004006344