Comparison of Cousin Biotech® Adhesix* versus conventional mesh in open anterior inguinal hernia repair: a Multi-centre, Randomised, Double-blinded, Controlled Clinical Trial.
Completed
- Conditions
- inguinal hernia10000073
- Registration Number
- NL-OMON38042
- Lead Sponsor
- Maastricht Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Male
Primary, unilateral inguinal hernia
Age >=18 years
ASA-score I-III
Signed informed consent
Elective surgery
Exclusion Criteria
Female
Bilateral and/or recurrent inguinal hernia
Femoral or scrotal hernia
Vasectomy
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is postoperative pain as reported during the first<br /><br>month with a special emphasis on analgesics use and pain experienced in the<br /><br>first two postoperative weeks.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Time to return to work<br /><br>Time to return to normal daily activity<br /><br>Time to first pain-free sexual intercourse<br /><br>Quality of Life measurement using General SF-36 Questionaire and disease<br /><br>specific Carolina's comfort Scale.<br /><br>Late postoperative pain<br /><br>Operation length<br /><br>Postoperative complications (e.g. infection, recurrence). </p><br>