Robotic <i>versus</i> laparoscopic minimally invasive inguinal hernia repair: randomized clinical trial (the ROGER trial)

Abstract

BACKGROUND: Superiority of robotic inguinal hernia repair compared with a laparoscopic minimally invasive approach remains unproven. The aim of this study was to evaluate postoperative pain after laparoscopic totally extraperitoneal repair (TEP) compared with robotic transabdominal preperitoneal repair (rTAPP). METHODS: This was a prospective, patient- and investigator-blinded, two-group, single-centre RCT conducted at a tertiary Swiss healthcare institution including 182 patients undergoing elective primary inguinal hernia repair. Patients were randomized 1 : 1 and stratified according to BMI and unilateral or bilateral hernia to either TEP or rTAPP. Surgery took place between March 2022 and November 2024. The primary endpoint was postoperative pain while coughing 24 h after surgery. Surgical workload (assessed using the National Aeronautics and Space Administration (NASA) Task Load Index (TLX)) was also recorded. RESULTS: In total, 91 patients (93% male, mean(s.d.) age of 56.8(15.2) years, mean(s.d.) BMI of 24.8(3) kg/m2, and 22% with bilateral hernias) were randomized to TEP and 91 patients (95% male, mean(s.d.) age of 55.1(14.5) years, mean(s.d.) BMI of 24.6(2.9) kg/m2, and 21% with bilateral hernias) were randomized to rTAPP. Primary outcome data were available for 90 TEP patients and 88 rTAPP patients. The median postoperative pain while coughing on a numeric rating scale 24 h after surgery was 5 (interquartile range (i.q.r.) 2-7) after TEP and 4 (i.q.r. 2-7) after rTAPP (P = 0.431, Cohen's d = 0.12). The mean(s.d.) operating time for unilateral hernias was 64.2(19.2) min for TEP and 80.3(20.9) min for rTAPP (P < 0.001). Ten (11%) postoperative complications occured after TEP and nine (10%) after rTAPP (P > 0.999). The mean(s.d.) NASA raw TLX score was 34.0(17.2) after TEP and 18.4(10.7) after rTAPP (P < 0.001). CONCLUSION: rTAPP demonstrated no superiority over TEP regarding postoperative pain and complication rates. rTAPP was associated with a reduced surgeon workload at the expense of a longer operating time. REGISTRATION NUMBER: NCT05216276 (http://www.clinicaltrials.gov).