Sutureless mesh in inguinal hernia repair
Completed
- Conditions
- Open repair of inguinal herniaDigestive SystemInguinal hernia
- Registration Number
- ISRCTN24964455
- Lead Sponsor
- James Paget University Hospital NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
All adult (both males and females, >16 years) patients who are to undergo conventional (open) repair of primary inguinal hernias. In general, all patients who are suitable for a conventional mesh repair are eligible for this trial.
Exclusion Criteria
1. Refusal of consent (these patients will receive the standard sutured mesh repair)
2. Recurrent hernia and bilateral hernia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measures as of 12/12/2012:<br>Pain, measured using the SF McGill Pain Questionnaire 4-6 hours and 3 months after surgery<br><br>Previous primary outcome measures until 12/12/2012:<br>Pain, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain) 4-6 hours after surgery, at 6 weeks and 1 year.
- Secondary Outcome Measures
Name Time Method 1. Chronic groin numbness, as reported at 6 weeks and 1 year after surgery<br>2. Recurrence of hernia, as determined by telephone enquiry of all participants at 6 weeks and 1 year after surgery, and confirmed by physical examination of those reporting either 'lump' or 'swelling'<br>3. Operating time: as recorded from 'knife-to-skin' to completion of skin closure