Robotic Inguinal vs Transabdominal Laparoscopic Inguinal Hernia Repair: The RIVAL Randomized Clinical Trial

Key PointsQuestionDoes the robotic approach to inguinal hernia repair result in improved postoperative outcomes compared with traditional laparoscopic inguinal hernia repairs? FindingsIn this randomized clinical trial of 102 patients with inguinal hernia, no significant differences in operative outcomes at 30 days were found between patients who received robotic inguinal hernia repair and those who received laparoscopic inguinal hernia repair in terms of postoperative pain, health-related quality of life, mobility, wound morbidity, or cosmesis. The robotic approach resulted in increased operative time, cost, and surgeon frustration, without discernible ergonomic benefit for surgeons. MeaningIn this study, no apparent clinical benefit occurred with the robotic approach compared with the laparoscopic approach to straightforward unilateral inguinal hernia. ImportanceDespite rapid adoption of the robotic platform for inguinal hernia repair in the US, to date, no level I trials have ever compared robotic inguinal hernia repair to laparoscopic repair. This multicenter randomized clinical trial is the first to compare the robotic platform to laparoscopic approach for minimally invasive inguinal hernia repair. ObjectiveTo determine whether the robotic approach to inguinal hernia repair results in improved postoperative outcomes compared with traditional laparoscopic inguinal hernia repairs. Design, Setting, and ParticipantsThis multicenter, single-blinded, prospective randomized clinical pilot study was conducted from April 2016 to April 2019, with a follow-up duration of 30 days in 6 academic and academic-affiliated sites. Enrolled in this study were 113 patients with a unilateral primary or recurrent inguinal hernia. After exclusions 102 remained for analysis. InterventionsStandard laparoscopic transabdominal preperitoneal repair or robotic transabdominal preperitoneal repair. Main Outcomes and MeasuresMain outcomes included postoperative pain, health-related quality of life, mobility, wound morbidity, and cosmesis. Secondary outcomes included cost, surgeon ergonomics, and surgeon mental workload. A primary outcome was not selected because this study was designed as a pilot study. The hypothesis was formulated prior to data collection. ResultsA total of 102 patients were included in the study (54 in the laparoscopic group, mean [SD] age, 57.2 [13.3] years and 48 [88.9%] male; 48 in the robotic group, mean [SD] age, 56.1 [14.1] years and 44 [91.6%] male). There were no differences at the preoperative, 1-week, or 30-day points between the groups in terms of wound events, readmissions, pain as measured by the Visual Analog Scale, or quality of life as measured by the 36-Item Short Form Health Survey. Compared with traditional laparoscopic inguinal hernia repair, robotic transabdominal preperitoneal repair was associated with longer median (interquartile range) operative times (75.5 [59.0-93.8] minutes vs 40.5 [29.2-63.8] minutes, respectively; P<.001), higher median (interquartile range) cost ($3258 [$2568-$4118] vs $1421 [$1196-$1930], respectively; P<.001), and higher mean (SD) frustration levels on the NASA Task Load Index Scale (range, 1-100, with lower scores indicating lower cognitive workload) (32.7 [23.5] vs 20.1 [19.2], respectively; P=.004). There were no differences in ergonomics of the surgeons between the groups as measured by the Rapid Upper Limb Assessment instrument. Conclusions and RelevanceResults of this study showed no clinical benefit to the robotic approach to straightforward inguinal hernia repair compared with the laparoscopic approach. The robotic approach incurred higher costs and more operative time compared with the laparoscopic approach, with added surgeon frustration and no ergonomic benefit to surgeons. Trial RegistrationClinicalTrials.gov Identifier: NCT02816658 This randomized clinical trial assesses whether the robotic approach to inguinal hernia repair results in improved postoperative outcomes compared with traditional laparoscopic inguinal hernia repairs in adult patients with inguinal hernia.