RCT Ventralex vs Onlay Mesh in Incisional Hernias (VPatchIncRCT)

Karolinska Institute

Status: Enrolling

Conditions: Incisional Hernia of Midline of Abdomen

Treatments: Device: Progrip; Device: Ventralex

Study type: Interventional

Funder types: Other

Identifiers

NCT04358159

VPatchIncRCT

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hernia defect 1-4 cm
• Incisional hernia or recurrent hernia after previous primary hernia repair
• BMI <35
• Age 18-100 years

Exclusion criteria

• Defect size>4 cm
• Ongoing pregnancy
• BMI>35
• Primary hernia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Ventralex

Experimental group

Description:

Repair with Ventralex patch in sublay position

Treatment:

Device: Ventralex

Progrip

Active Comparator group

Description:

Repair with Progrip in Onlay position

Treatment:

Device: Progrip