RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair

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

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®.

Quality of life measurement based on the occurrence of a foreign body sensation for more than 3 months within 12 month after surgery.

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.

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