The HELI pilot: clinical research to investigate the possibility of fixation of the polypropylene mesh with autologous growth factor fibrin glue in hernia inguinalis surgery.
Phase 2
Completed
- Conditions
- hernia1001076110041297
- Registration Number
- NL-OMON30095
- Lead Sponsor
- Catharina-ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
primary unilateral hernia inguinalis
male
at least 18 years of age
sufficient knowledge of the Dutch language
competent to make their own decisions
ASA-1 or ASA-2
informed consent is signed
Exclusion Criteria
female
male with scrotal hernia
age under 18
incompetent of making decisions
lack of understanding the Dutch language
previous groin surgery
ASA-3 or ASA-4
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Recurrence rate (max 10%)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pain score day 1, 14 after surgery<br /><br>Pain score 3 months after surgery</p><br>