Lichtenstein versus Onstep for inguinal hernia repair: protocol for a double-blinded randomised trial.

INTRODUCTION: Inguinal hernia is a common condition that affects millions of people world-wide every year. In Denmark (population of 5.5 million), more than 10,000 repairs of inguinal hernias are performed annually. The optimal surgical procedure for mesh placement and fixation is still being debated because of long-term complications such as persisting pain and impairment of sexual function. The Onstep approach is a newer type of groin hernia repair with promising preliminary results in terms of very few cases of chronic pain and recurrences. This protocol describes a randomised clinical trial the objective of which is to evaluate chronic pain and sexual dysfunction after inguinal hernia repair using the Lichtenstein repair compared with the Onstep approach.
MATERIAL AND METHODS: The study is designed as a two-arm blinded multicentre, randomised clinical trial, currently involving five centres in Denmark and with ongoing recruitment. The plan is to recruit a total of 282 patients (Lichtenstein, n = 141 and Onstep, n = 141) and to perform one-year follow-ups. Follow-up will be done by clinical examination, phone interviews and questionnaires.
CONCLUSION: This study will be the first randomised clinical trial to compare the Lichtenstein repair with the Onstep technique. The results are important in order to guide further research and clinical guidelines for inguinal hernia repair. FUNDING: The study was funded in part by Bard Europe. TRIAL REGISTRATION: NCT01753219 (clinicaltrials.gov).

RCT Entities:   Population Interventions Outcomes