Design of a comparative outcome analysis of open, laparoscopic, or robotic-assisted incisional or inguinal hernia repair utilizing surgeon experience and a novel follow-up model

Abstract

Background: In a recent publication, the International Guidelines for Groin Hernia Management by the European Hernia Society (EHS) recognized the need to individualize and tailor the surgical approach for hernia repair. There may be different opportunities for optimization of the surgical technique for surgeons performing open, laparoscopic, or robotic-assisted hernia repair. Robotic-assisted hernia repair is a relatively new minimally invasive surgical approach compared to laparoscopic and open repair. Currently, there is a lack of comparative prospective studies designed to evaluate long-term outcomes of patients undergoing robotic-assisted, laparoscopic, or open hernia repair.

Materials & methods: This manuscript presents an innovative study design with two study cohorts (incisional and inguinal hernia repair) that contain three arms (robotic-assisted, laparoscopic, and open). The trial objective is to collect short-term and long-term outcomes for patients undergoing robotic-assisted, laparoscopic, or open hernia repair. The present publication will discuss the trial design, methods used to ensure consistency in surgeon expertise, and provides strategies to obtain long-term (> 3 months) follow-up data for enrolled patients.

Results: One hundred subjects underwent incisional and one hundred underwent inguinal hernia repair at the time of this manuscript. Surgeon experience was analyzed across the three surgical techniques and follow-up compliance was assessed through 1 year. The follow-up completion rates for both study cohorts were >80% for all visits.

Conclusions: The innovative trial design helped to improve the quality and quantity of long-term follow-up. More innovative options to improve patient retention may be tested in future trials of similar design.

Trial registration: ClinicalTrials.gov NCT02715622.

Keywords: Clinical trial design; Follow-up compliance; Incisional hernia; Inguinal hernia; Laparoscopy; Open repair; Patient retention; Robotic-assisted; Surgeon experience.