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


- candidate number24928
- NTR NumberNTR6054
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-aug-2016
- Secondary IDs24928 ISRCTN14511362
- Public TitleTREPP compared to Lichtenstein's technique for inguinal hernia: what's best?
- Scientific TitleProtocol for a randomised clinical trial comparing the Trans REctussheath PrePeritoneal repair (TREPP) versus Lichtenstein's technique for inguinal hernia
- ACRONYMthe TREPPoLi trial
- hypothesisInguinal hernia repair according to the TREPP technique results in less patients with chronic postoperative inguinal pain (CPIP) compared to Lichtenstein's technique.
- Healt Condition(s) or Problem(s) studiedHernia inguinal, Surgery
- Inclusion criteriaParticipant inclusion criteria
1. Aged 18 years and over
2. ASA classification 1-3
3. Symptomatic primary unilateral inguinal hernia
- Exclusion criteriaParticipant 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)
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2016
- planned closingdate31-dec-2019
- Target number of participants750
- InterventionsTREPP (interventie, zie ook het artikel the nine steps of TREPP op PubMed)

Lichtenstein (controle interventie)
- Primary outcomePrimary outcome measures

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 outcomeSecondary outcome measures

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)
- Timepoints- Basis meting op poli heelkunde bij aanvang
- 6 weken postoperatief
- 6maanden postoperatief
- 1 jaar postoperatief
- Trial web sitewww.liesbreukcentrumNoordNederland.nl (under construction)
- statusplanned
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator Stichting Adriaan Metius, Cooperatie Heelkunde Friesland, Medical Center Leeuwarden
- Funding
(Source(s) of Monetary or Material Support)
Stichting Adriaan Metius
- PublicationsTREPP in 9 steps (Akkersdijk et al, Int J Surgery 2016: 150-54)

Protocol will be published prior to the start of the trial
- Brief summaryBackground
Treatment of the inguinal hernia with a tension-free mesh has reduced the incidence of hernia recurrence. Chronic pain has become the main postoperative complication after surgical inguinal hernia repair, especially following the Lichtenstein technique. Preliminary experiences with a soft mesh positioned in the preperitoneal space (PPS) either by transinguinal preperitoneal (TIPP) or total extraperitoneal (TEP) approach, showed promising results considering the reduction of postoperative chronic pain. TEP and Lichtenstein are currently preferred techniques in guidelines worldwide. However, the ongoing evolution of surgical innovations for inguinal hernia repair led to an open direct approach with preperitoneal mesh position. Based on the Ďopení (or anterior) TIPP procedure, another preperitoneal repair was developed: the transrectus sheath preperitoneal (TREPP) mesh repair, which comprises nine surgical steps.

Methods
The TREPPoLi trial is a modern multicenter randomised clinical trial comparing TREPP versus Lichtenstein from patientsí, societal- and from hospital perspectives. Patients will be randomly allocated to anterior inguinal hernia repair according to the TREPP mesh repair or Lichtensteinís procedure in one of the participating expertise centers. All patients with a primary unilateral inguinal hernia, eligible for operation, will be invited to participate in the trial. The primary outcome measure will be differences in chronic postoperative inguinal pain (CPIP) of TREPP and Lichtenstein. Secondary outcome measures will be serious adverse events (SAEs), recurrence, hemorrhage, return to daily activities (for example work), operative time, learning curve and costs. Alongside the trial a health status study, quantitative sensory testing (QST) measuring and an economic evaluation will be performed. To demonstrate that inguinal hernia repair according to the TREPP technique compared with Lichtenstein reduces the amount of patients with CPIP from 12% to <5%, a sample size of 750 patients is required (two-sided test, α = 0.03, 90% power), one group of 375 patients will be randomised to TREPP and the other 375 patients will be randomised to Lichtensteinís technique. The trial was conducted warranting the risk for bias in line with the Cochrane Handbook suggestions and advices.

Conclusion
The TREPPoLi trial aims to evaluate the TREPP and Lichtenstein from patientsí perspective with in mind: the possible risk-of-bias prevention according to the 3 dimensions. All outcomes will be evaluated in line with verified patient reported outcomes (vPROís) and will focus on the amount of patients with CPIP, health status, learning curve and the costs from hospital and societal perspective. It is hypothesized that the TREPP technique may reduce the amount of patients with CPIP compared to the Lichtenstein procedure and that the TREPP may be easier to learn.

Trial registration: in progress.

Trial status: not started

Trial supervision: professor J.P.E.N. Pierie, MD, PhD and G.G. Koning, MD, PhD, both are surgeons at Medical Center Leeuwarden, Leeuwarden, the Netherlands on behalf of HeelkundeFriesland.nl
- Main changes (audit trail)
- RECORD8-aug-2016 - 3-nov-2016


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