TREPP reduces the amount of patients with chronic postoperative inguinal pain (CPIP) compared with Lichtenstein's technique.
Conditions
Interventions
TREPP (interventie, zie ook het artikel the nine steps of TREPP op PubMed)
Lichtenstein (controle interventie)
Sponsors
Stichting Adriaan Metius
Cooperatie Heelkunde Friesland
Medisch Centrum Leeuwarden
Eligibility
Inclusion criteria
Inclusion criteria: Participant inclusion criteria 1. Men and women with a symptomatic primary unilateral inguinal hernia 2. Aged 18 years and over 3. ASA classification 1-3 4. Signed informed consent
Exclusion criteria
Exclusion criteria: Participant exclusion criteria 1. Previous preperitoneal operations (e.g. prostatectomy, Caesarean section) 2. Bilateral hernias 2. Recurrent hernias 3. ASA classification 4. Incarcerated hernias (acute) 5. psychiatric disease, or other reasons making follow-up or questionnaires unreliable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chronic postoperative inguinal pain (CPIP) is measured using a visual analogue scale (VAS) in combination with the proposed modified (bedside) 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)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) | — |
Outcome results
None listed