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

Large Midline Ventral Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03793738
• Other study ID #: 01004006344
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Tbilisi State Medical University
• Contact: Zaza Demetrashvili, MD, PhD
• Phone: +995599217733
• Email: zdemetr[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Large Midline Ventral Hernia

Intervention

Procedure:
• Anterior component separation

• Posterior component separation

Locations

Country	Name	City	State
Georgia	Tbilisi State Medical University	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Zaza Demetrashvili

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia recurrence	Develop of ventral hernia recurrence	during 3 year after surgery
Secondary	Wound complications	Develop of wound complications (seroma, hematoma, surgical site infection)	30 day after surgery