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Original Investigation
March 18, 2020

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

Author Affiliations
  • 1Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, Cleveland Clinic, The Cleveland Clinic Foundation, Cleveland, Ohio
  • 2Comprehensive Hernia Center, Department of Surgery, University of South Carolina School of Medicine Greenville, Greenville
  • 3Department of Surgery, New Hanover Regional Medical Center, University of North Carolina Wilmington, Wilmington
  • 4Department of Surgery, Medical College of Wisconsin, Milwaukee
  • 5Department of Surgery, Mount Sinai Hospital, New York, New York
  • 6Department of Surgery, Washington University in St Louis, St Louis, Missouri
  • 7Department of Surgery, University of North Carolina at Chapel Hill, Chapel Hill
  • 8Department of Surgery, University of Texas Medical Branch, Galveston
JAMA Surg. Published online March 18, 2020. doi:10.1001/jamasurg.2020.0034
Key Points

Question  Does the robotic approach to inguinal hernia repair result in improved postoperative outcomes compared with traditional laparoscopic inguinal hernia repairs?

Findings  In 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.

Meaning  In this study, no apparent clinical benefit occurred with the robotic approach compared with the laparoscopic approach to straightforward unilateral inguinal hernia.

Abstract

Importance  Despite 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.

Objective  To determine whether the robotic approach to inguinal hernia repair results in improved postoperative outcomes compared with traditional laparoscopic inguinal hernia repairs.

Design, Setting, and Participants  This 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.

Interventions  Standard laparoscopic transabdominal preperitoneal repair or robotic transabdominal preperitoneal repair.

Main Outcomes and Measures  Main 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.

Results  A 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 Relevance  Results 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 Registration  ClinicalTrials.gov Identifier: NCT02816658

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