Inguinal hernia Surgery Inguinal hernia
Conditions
Interventions
As of 04/01/2012 the status of this record was changed to 'stopped' as the trial never started.
900 patients will be randomly allocated to anterior
inguinal hernia repair according to the transingui
Sponsors
Radboud University Medical Centre, Nijmegen (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Primary groin hernia, unilateral 2. Age > 18, < 80 years 3. American Society of Anaesthesiologists (ASA) classification 1-3 4. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Recurrences 2. Age 80 years 3. Scrotal hernia 4. ASA classification >4 5. Acute incarcerated inguinal hernia 6. Psychiatric disease or other factors which make follow up or questionnaires unreliable 7. Previous preperitoneal surgery (e.g. radical prostatectomy) 8. Joint sessions (urology, vasectomy etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of adverse events 2. Chronic pain (Visual Analogue Score [VAS]) Data will be collected by VAS-diary and SF36-list (Health Status / Quality of Life). Digital forms will be filled in by the patients at the outpatient departments at 14 days, 3 months and one year after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Costs 2. Quality of life (SF-36) 3. Return to daily activities 4. Return to work Data will be collected by VAS-diary and SF36-list (Health Status / Quality of Life). Digital forms will be filled in by the patients at the outpatient departments at 14 days, 3 months and one year after surgery. | — |
Countries
Netherlands
Outcome results
None listed