NCT04961346

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: —
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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®.

Conditions

• Incisional Hernia

Interventions

Type	Name	Description
DEVICE	Ultrapro® mesh	large-pore, lightweight polypropylene mesh
DEVICE	Premilene® mesh	small-pore, heavyweight polypropylene mesh

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-06-01
• Completion: 2009-06-01
• First posted: 2021-07-14
• Last updated: 2021-07-23

Locations

1 site across 1 country: Germany