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Comparison of Self-adhering Mesh and Conventional Mesh in Inguinal Hernia Repair.

NCT01334775 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-01-09

No results posted yet for this study

Summary

Inguinal hernia repair coincides with a high rate of postoperative pain, extending to over a year in 10-20% of patients. Although this is of major concern, early postoperative pain also has an important impact on patients and their ability to regain normal work and activities. Since inguinal hernia repair is the most frequently performed operation worldwide, a small reduction in loss of workdays can already have significant impact on financial issues. As for the origin of the pain, it might be the result of local inflammation caused by the mesh material, but also by nerve entrapment due to fixation techniques. The development of a new mesh which enables sutureless fixation, Cousin Biotech® Adhesix™, may overcome pain related to fixation techniques used in the open hernia repair procedure according to Lichtenstein. Furthermore, the Cousin Biotech® Adhesix™ mesh has already been in use in our institutions and surgeons familiarized themselves with the application.

The investigators would like to conduct a multicentre randomised controlled clinical trial to compare the difference in early postoperative pain after unilateral primary inguinal hernia repair in males. The procedures will be performed in day surgery. Early postoperative pain is defined as the pain during the first month, with a special interest in the first two weeks. In addition, the investigators want to measure the possible benefit in terms of time to return to work, daily activities, quality of life, operation length, complications and long term postoperative pain.

Conditions

  • Inguinal Hernia

Interventions

PROCEDURE

Open anterior inguinal hernia repair

Placement of a surgical mesh in open anterior inguinal hernia repair.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Orbis Medical Centre

    collaborator OTHER

  • VieCuri Medical Centre

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Nicole D. Bouvy, MD, PhD · Maastricht University Medical Centre, dept. of General Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Netherlands

Study Locations

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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 NCT01334775 on ClinicalTrials.gov