RCT Ventralex vs Onlay Mesh in Incisional Hernias

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Incisional Hernia of Midline of Abdomen

Intervention / Treatment
-----------------
* Device: Ventralex
* Device: Progrip


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial of Vantralex versus Progrip for repair of midline incisional hernias
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ventralex<br>Repair with Ventralex patch in sublay position | Device: Ventralex<br>* Repair of the hernia by a Ventralex patch in sublay position<br>|
| Active Comparator: Progrip<br>Repair with Progrip in Onlay position | Device: Progrip<br>* Repair of the hernia by a Progrip mesh in onlay position<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | Rate of hernia recurrences diagnosed at clinical and/or radiologic examination | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate ofntra- and postoperative complications | Rate of complications occurring during or after the repair | 30 days | 
| Rate of seroma | Postoperative seroma | one year | 
| Persisting postoperative pain | Pain interfering with daily activities as rated with Ventral Hernia Pain Questionnaire | One year | 
| Sick leave | Mean number of postoperative days sick leave | 30 days |