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

Study Overview
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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.

Official Title
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Comparison of Cousin Biotech® Adhesix™ Versus Conventional Mesh in Open Anterior Inguinal Hernia Repair: a Multi-centre, Randomised, Double-blinded, Controlled Clinical Trial.

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: Open anterior inguinal hernia repair


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental - Cousin Biotech Adhesix<br>Placement of a self-adhering (sutureless) surgical mesh in open anterior inguinal hernia repair | Procedure: Open anterior inguinal hernia repair<br>* Placement of a surgical mesh in open anterior inguinal hernia repair.<br>* Other names: Cousin Biotech Biomesh P8;|
| Active Comparator: Conventional - Cousin Biotech Biomesh P8<br>Placement of the conventional (sutured) surgical mesh in open anterior inguinal hernia repair | Procedure: Open anterior inguinal hernia repair<br>* Placement of a surgical mesh in open anterior inguinal hernia repair.<br>* Other names: Cousin Biotech Biomesh P8;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in early postoperative pain scores | Measured with VAS-scores | 0-4 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in long-term postoperative pain scores | Measured with VAS-scores | 4 weeks - 12 months after surgery | 
| Number of days to return to normal daily activities |  | 0-12 months after surgery | 
| Number of days to return to work |  | 0-12 months after surgery | 
| Differences in use of analgesics | Measured: frequency, dose and type. | 0-12 months after surgery | 
| Differences in reported Quality of life | Measured with SF-36 questionnaire | 0-12 months after surgery | 
| Number of patients with complications/adverse events | All adverse events/complications are recorded (i.e. infection, recurrence, bleeding) | 0-12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal hernia, Postoperative pain, Surgical mesh