A double-blind randomized controlled trial comparing PArietene self-fixing semi-Resorbable mesh with standard heavy-weight polypropylene mesh on chronic inguinal pAin DEvelopment
Completed
- Conditions
- Chronic pain after inguinal hernia repair10041297
- Registration Number
- NL-OMON31651
- Lead Sponsor
- Tyco Health Care
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 350
Inclusion Criteria
1. Primary unilateral inguinal hernia
2. Age: * 18 years old
Exclusion Criteria
1. Signs of incarceration
2. Signs of local infection
3. Presence of chronic inguinal pain following a previous vasectomy, Pfannenstiel incision, appendectomy
4. ASA IV
5. Adequate follow up not possible: mental retardation, dementia, foreign language, living in asylum seekers centre
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pain assessment (6-point Verbal Rating Scale and Surgical Pain Scales)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Recurring inguinal hernia (physical examination/ ultrasonography), peri- and<br /><br>early postoperative complications (questionnaire), return to daily actvities<br /><br>(questionnaire), quality of life (SF-36)</p><br>