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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental - Cousin Biotech Adhesix

Placement of a self-adhering (sutureless) surgical mesh in open anterior inguinal hernia repair

Group Type EXPERIMENTAL

Open anterior inguinal hernia repair

Intervention Type PROCEDURE

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

Conventional - Cousin Biotech Biomesh P8

Placement of the conventional (sutured) surgical mesh in open anterior inguinal hernia repair

Group Type ACTIVE_COMPARATOR

Open anterior inguinal hernia repair

Intervention Type PROCEDURE

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

Interventions

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Open anterior inguinal hernia repair

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

Intervention Type PROCEDURE

Other Intervention Names

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Cousin Biotech Adhesix Cousin Biotech Biomesh P8

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No