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

Not Applicable

Recruiting

• Conditions: Large Midline Ventral Hernia
• Interventions: Procedure: Posterior component separation; Procedure: Anterior component separation

• Registration Number: NCT03793738
• Lead Sponsor: Zaza Demetrashvili

Brief Summary

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

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 Timeline

• Study Start: 2016-12
• Study First Submitted: 2018-12-27
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-19
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
posterior component separation	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.
anterior component separation	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.

Primary Outcome Measures

Name	Time	Method
Hernia recurrence	during 3 year after surgery	Develop of ventral hernia recurrence

Secondary Outcome Measures

Name	Time	Method
Wound complications	30 day after surgery	Develop of wound complications (seroma, hematoma, surgical site infection)

Trial Locations

Locations (1)

Tbilisi State Medical University; 🇬🇪 Tbilisi, Georgia