RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair

Study Overview
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Brief Summary
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In this randomized, controlled, prospective multicentre clinical trial with a parallel group design a large-pore, lightweight polypropylene mesh (Ultrapro®) is compared to a small-pore, heavyweight polypropylene mesh (Premilene®), within a standardized, retromuscular mesh augmentation to identify the superiority of the lightweight mesh. Included patients are examined at five scheduled follow-up visits (5 and 21 days, 4, 12 and 24 months after surgery). The primary outcome criterion is foreign body sensation 12 month after surgery. Further secondary endpoint criteria are the occurrence of haematoma or haematoma requiring surgery at the 5-day visit, seroma, wound infection, and chronic pain within 24 months postoperatively. Quality of life was investigated by the SF-36®.

Official Title
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Sublay Technique With Retromuscular Mesh Augmentation for Incisional Hernia Repair - A Prospective Randomized Multicentre Trial Comparing Lightweight Versus Heavyweight Meshes

Conditions
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Incisional Hernia

Intervention / Treatment
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* Device: Ultrapro® mesh
* Device: Premilene® mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fascial defect after vertical midline laparotomy with a minimum of 4 cm in diameter Exclusion Criteria: hernia of other location recurrent hernia incarcerated hernia emergency surgery patients with a malignancy or chemotherapy within the last 3 months pregnancy participation in other studies patients with a wound infection missing informed consent

Ages Eligible for Study
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Minimum Age: 18 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrapro®<br>Participants received incisional hernia repair with an Ultrapro mesh in a sublay technique. | Device: Ultrapro® mesh<br>* large-pore, lightweight polypropylene mesh<br>|
| Experimental: Premilene®<br>Participants received incisional hernia repair with a Premilene mesh in a sublay technique. | Device: Premilene® mesh<br>* small-pore, heavyweight polypropylene mesh<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| foreign body sensation | Quality of life measurement based on the occurrence of a foreign body sensation for more than 3 months within 12 month after surgery. | 12 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative seroma | Fluid collection in the wound area | 24 month | 
| wound infection | Clinical identification of superficial and deep wound infections. | 24 month | 
| haematoma | hematoma in the wound area | 5 days | 
| hematoma requiring surgery | hematoma in the wound area requiring surgery | 5 days | 
| chronic pain | Chronic pain is defined as pain sensations that persist for more than 3 months after surgery. A Visual Analog Scale (VAS) with a range of 0-10 is used as a tool to measure pain. | 24 month | 
| hernia recurrence | hernia recurrence is defined as a new abdominal wall defect in the area of surgery | 24 month |