Primary unilateral inguinal hernia Musculoskeletal Diseases Primary unilateral inguinal hernia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and over 2. ASA classification 1-3 3. Symptomatic primary unilateral inguinal hernia
Exclusion criteria
Exclusion criteria: 1. Previous preperitoneal operations (e.g. prostatectomy, Caesarean section) 2. Bilateral hernias 2. Recurrent hernias 4. Incarcerated hernias (acute) 5. Inadequate mental state and/or IQ limitations to answer questionnaires 6. Mental disorders (DSM V)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chronic postoperative inguinal pain (CPIP) is measured using a visual analogue scale (VAS) in combination with the proposed Quantitative sensory testing (QST) at baseline, 6 weeks, 6 months and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health status is measured using the Short Form 36 (SF-36), EuroQol5D (EQ-5D), Carolina comfort scale and Pain Disability index and a physical examination at baseline, 6 weeks, 6 months and 1 year 2. Cost-effectiveness of the interventions is completed by calculating all direct and/or indirect costs (hospital and societal related costs) at 12 months (this means: at the end of the trial, once the last patient fulfilled the final visit) | — |
Countries
Netherlands