Clinical trial NCT01334775: Comparison of Self-adhering Mesh and Conventional Mesh in Inguinal Hernia Repair.
Official title: Comparison of Cousin Biotech® Adhesix™ Versus Conventional Mesh in Open Anterior Inguinal Hernia Repair: a Multi-centre, Randomised, Double-blinded, Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inguinal Hernia
Keywords: Inguinal hernia
Postoperative pain
Surgical mesh
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Orbis Medical Centre
name: VieCuri Medical Centre
First posted: 2011-04-13
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Male
* Primary, unilateral inguinal hernia
* Age ≥18 years
* Social status: professionally employed
* ASA-score I-III
* Signed informed consent
* Elective surgery

Exclusion Criteria:

* Female
* Bilateral and/or recurrent inguinal hernia
* Femoral or scrotal hernia
* Vasectomy
* Social status: unemployed
* Chronic use of pain medication
* Symptomatic acute hernia (i.e. bowel obstruction, incarceration, strangulation, peritonitis or perforation of bowel contents)
* ASA-score IV or above
* Incapacitated adult or no signed informed consent
* Patient is unable to speak Dutch

Primary outcomes:
measure: Difference in early postoperative pain scores
timeFrame: 0-4 weeks after surgery
Secondary outcomes:
measure: Difference in long-term postoperative pain scores
timeFrame: 4 weeks - 12 months after surgery
measure: Number of days to return to normal daily activities
timeFrame: 0-12 months after surgery
measure: Number of days to return to work
timeFrame: 0-12 months after surgery
measure: Differences in use of analgesics
timeFrame: 0-12 months after surgery
measure: Differences in reported Quality of life
timeFrame: 0-12 months after surgery
measure: Number of patients with complications/adverse events
timeFrame: 0-12 months after surgery
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre Amsterdam, dept. of Surgery
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre, dept. of General Surgery
city: Sittard-Geleen
country: Netherlands
facility: Orbis Medical Centre
city: Venlo
country: Netherlands
facility: VieCuri Medical Centre, dept. of General Surgery
Study officials:
affiliation: Maastricht University Medical Centre, dept. of General Surgery
name: Nicole D. Bouvy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: