MedTrace Logo

RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair

NCT04961346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2021-07-23

No results posted yet for this study

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

DEVICE

Ultrapro® mesh

large-pore, lightweight polypropylene mesh

DEVICE

Premilene® mesh

small-pore, heavyweight polypropylene mesh

Sponsors & Collaborators

  • RWTH Aachen University

    lead OTHER

Principal Investigators

  • Ralf D Hilgers, Professor · Institute for Medical Statistics, RWTH Aachen University Hospital, Aachen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2007-06-30
Completion
2009-06-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04961346 on ClinicalTrials.gov