RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair

Not Applicable

Completed

• Conditions: Incisional Hernia
• Interventions: Device: Ultrapro® mesh; Device: Premilene® mesh

• Registration Number: NCT04961346
• Lead Sponsor: RWTH Aachen University

Brief 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®.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2007-06
• Study Completion: 2009-06
• Study First Submitted: 2021-06-16
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-04
• Study First Posted: 2021-07-14
• Last Update Submitted: 2021-07-16
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 188

Inclusion Criteria

• fascial defect after vertical midline laparotomy with a minimum of 4 cm in diameter

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrapro®	Ultrapro® mesh	Participants received incisional hernia repair with an Ultrapro mesh in a sublay technique.
Premilene®	Premilene® mesh	Participants received incisional hernia repair with a Premilene mesh in a sublay technique.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
wound infection	24 month	Clinical identification of superficial and deep wound infections.
haematoma	5 days	hematoma in the wound area
hematoma requiring surgery	5 days	hematoma in the wound area requiring surgery
postoperative seroma	24 month	Fluid collection in the wound area
chronic pain	24 month	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.
hernia recurrence	24 month	hernia recurrence is defined as a new abdominal wall defect in the area of surgery

Trial Locations

Locations (1)

Department of Surgery, University Hospital Aachen; 🇩🇪 Aachen, NRW, Germany