RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair

NCT ID: NCT04961346

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2009-06-30

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®.

Conditions

Incisional Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ultrapro®

Participants received incisional hernia repair with an Ultrapro mesh in a sublay technique.

Group Type: EXPERIMENTAL

Ultrapro® mesh

Intervention Type: DEVICE

large-pore, lightweight polypropylene mesh

Premilene®

Participants received incisional hernia repair with a Premilene mesh in a sublay technique.

Group Type: EXPERIMENTAL

Premilene® mesh

Intervention Type: DEVICE

small-pore, heavyweight polypropylene mesh

Interventions

Ultrapro® mesh

large-pore, lightweight polypropylene mesh

Intervention Type: DEVICE

Premilene® mesh

small-pore, heavyweight polypropylene mesh

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Andreas Kroh, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ralf D Hilgers, Professor

Role: PRINCIPAL_INVESTIGATOR

Institute for Medical Statistics, RWTH Aachen University Hospital, Aachen, Germany

Locations

Department of Surgery, University Hospital Aachen

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

References

Kroh A, Zufacher M, Eickhoff R, Heise D, Helmedag M, Ulmer F, Neumann UP, Conze J, Hilgers RD, Binnebosel M. No difference in outcomes between large- and small-pore meshes in a prospective, randomized, multicenter trial investigating open retromuscular meshplasty for incisional hernia repair. Langenbecks Arch Surg. 2023 Jan 13;408(1):22. doi: 10.1007/s00423-022-02751-x.

Reference Type: DERIVED

PMID: 36635466 (View on PubMed)

Other Identifiers

Ultrapo-Studie

Identifier Type: -

Identifier Source: org_study_id