Inguinal Hernia
Conditions
Keywords
Inguinal hernia, Postoperative pain, Surgical mesh
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.
Interventions
PROCEDUREOpen anterior inguinal hernia repair
Placement of a surgical mesh in open anterior inguinal hernia repair.
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Orbis Medical Centre
VieCuri Medical Centre
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in early postoperative pain scores | 0-4 weeks after surgery | Measured with VAS-scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in long-term postoperative pain scores | 4 weeks - 12 months after surgery | Measured with VAS-scores |
| 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 | 0-12 months after surgery | Measured: frequency, dose and type. |
| Differences in reported Quality of life | 0-12 months after surgery | Measured with SF-36 questionnaire |
| Number of patients with complications/adverse events | 0-12 months after surgery | All adverse events/complications are recorded (i.e. infection, recurrence, bleeding) |
Countries
Netherlands
Outcome results
None listed