Open repair of inguinal hernia Digestive System Inguinal hernia
Conditions
Interventions
This is a randomised controlled single-blind (patients) trial.
For the study group, a Progrip™ mesh will be used. This is a lightweight mesh that does not have to be sutured in place, because its de
Sponsors
James Paget University Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Refusal of consent (these patients will receive the standard sutured mesh repair) 2. Recurrent hernia and bilateral hernia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 12/12/2012: Pain, measured using the SF McGill Pain Questionnaire 4-6 hours and 3 months after surgery Previous primary outcome measures until 12/12/2012: 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
| Measure | Time frame |
|---|---|
| 1. Chronic groin numbness, as reported at 6 weeks and 1 year after surgery 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' 3. Operating time: as recorded from 'knife-to-skin' to completion of skin closure | — |
Countries
United Kingdom
Outcome results
None listed