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TREPP compared to Lichtenstein's technique for inguinal hernia: what's best?

Protocol for a randomised clinical trial comparing the Trans REctussheath PrePeritoneal repair (TREPP) versus Lichtenstein's technique for inguinal hernia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14511362
Enrollment
750
Registered
2016-07-29
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary unilateral inguinal hernia Musculoskeletal Diseases Primary unilateral inguinal hernia

Interventions

Following provision of informed consent, participants are randomised to one of two groups. Group 1: Participants undergo inguinal hernia repair according to the TREPP technique. To re
a soft mesh will be used instead of the ‘heavy’ polypropylene mesh. The mesh will be positioned as onlay (or ‘inlay’, as it is, basically, positioned IN the inguinal canal). The skin will be closed th

Sponsors

Medical Center Leeuwarden
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026