NCT04358159

RCT Ventralex vs Onlay Mesh in Incisional Hernias

Randomised Controlled Trial of Ventralex Versus Onlay Mesh Repair for Midline Incisional Hernias

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

A radomised controlled trial comparing Ventralex patch and Progrip mesh in surgery for midline incisional hernias

Detailed description

Incisional hernias in the midline is among the most common conditions requiring surgery. There are several factors which can increase the risk of incisional hernias, e.g. surgical technique, truncal obesity and other co-morbidities. Repair with mesh-reinforcement is considered standard for the treatment of incisional hernias. Onlay and sublay mesh placements are the most commonly used methods. There are many different types of mesh available to use. Despite the widely use of composite ventral-patch Ventralex, there are few studies with small numbers of patients showing the advantage and disadvantage of ventral-patch. Some studies show that the onlay mesh-reinforcement remains a good alternative to the sublay mesh technique, while others showing fewer recurrences with the sublay mesh technique. The Ventralex mesh is usually placed on the peritoneum as a Intra peritoneum onlay mesh (IPOM). In this study intend to compare pre peritoneal Ventralex® mesh in sublay position with ProGrip self-fixating onlay mesh.

Conditions

• Incisional Hernia of Midline of Abdomen

Interventions

Type	Name	Description
DEVICE	Ventralex	Repair of the hernia by a Ventralex patch in sublay position
DEVICE	Progrip	Repair of the hernia by a Progrip mesh in onlay position

Timeline

• Start date: 2021-01-01
• Primary completion: 2026-09-30
• Completion: 2027-09-30
• First posted: 2020-04-24
• Last updated: 2025-08-13

Locations

2 sites across 1 country: Sweden