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

Background

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 ‘open’ (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 prospective multicenter randomised clinical trial comparing TREPP versus Lichtenstein from patients’, societal- and from hospital perspectives. Patients will be randomly allocated to anterior inguinal hernia repair according to the TREPP mesh repair or Lichtenstein’s 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, return to daily activities (for example work), operative timeand costs. Alongside the trial a health status study and quantitative sensory testing (QST) 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 6%, (a 50% decrease) a sample size of 952 patients is required (two-sided test, α = 0.05, 90% power), one group of 476 patients will be randomised to TREPP and the other 476 patients will be randomised to Lichtenstein’s 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 patients’ perspective.All outcomes will be evaluated in line with verified patient reported outcomes (vPRO’s) and will focus on the amount of patients with CPIP and health status.. 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, surgeon at Medisch Centrum Leeuwarden,and G.G. Koning, MD, PhD, surgeon at Noordwest Ziekenhuisgroep, the Netherlands on behalf of HeelkundeFriesland.nl

Inguinal hernia repair according to the TREPP technique results in less patients with chronic postoperative inguinal pain (CPIP) compared to Lichtenstein's technique.

- First visit: inclusion, baseline measurements

- 6 weeks postoperative: VAS and physical examination.

- 6 months postoperative: questionnaires and QST.

- 1 year postoperatively: questionnaires and QST

TREPP (interventie, zie ook het artikel the nine steps of TREPP op PubMed)

Lichtenstein (controle interventie)