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Randomized Controlled Trial
. 2020 May 1;155(5):380-387.
doi: 10.1001/jamasurg.2020.0034.

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

Ajita S Prabhu  1 , Alfredo Carbonell  2 , William Hope  3 , Jeremy Warren  2 , Rana Higgins  4 , Brian Jacob  5 , Jeffrey Blatnik  6 , Ivy Haskins  1   7 , Hemasat Alkhatib  1 , Luciano Tastaldi  1   8 , Aldo Fafaj  1 , Chao Tu  1 , Michael J Rosen  1
Affiliations
Randomized Controlled Trial

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

Ajita S Prabhu et al. JAMA Surg. .

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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Conflict of interest statement

Conflict of Interest Disclosures: Dr Prabhu reported receiving honoraria for speaking and a research grant paid to her institution from Intuitive Surgical, serving on an advisory board and receiving honoraria from Medtronic and from BD. Dr Carbonell reported receiving honoraria from Intuitive Surgical, Ethicon, and WL Gore & Associates, as well as a research grant from WL Gore & Associates paid to his institution. Dr Hope reported receiving honoraria from speaking from BD, WL Gore & Associates, Intuitive Surgical, honoraria for consulting from BD, Intuitive Surgical, Medtronic, research grant support paid to his institution from BD, and being on the surgeon advisory board for Mesh Suture and Deep Blue. Dr Warren reported receiving honoraria for teaching and speaking from Intuitive Surgical, honoraria for consulting from CMR surgical, and honoraria for speaking from Ethicon. Dr Higgins reported receiving honoraria for teaching from Intuitive Surgical, and honoraria for teaching and speaking from WL Gore & Associates. Dr Jacob reported receiving honoraria from Medtronic, grant support for conferences from Medtronic, having equity in IHC Inc, and receiving honoraria from BD. Dr Blatnik reported receiving honoraria from Intuitive Surgical and BD for consulting and teaching, and receiving research support paid to his institution from Ethicon and Cook. Dr Rosen reported receiving salary support for his role as Medical Director of the Americas Hernia Society Quality Collaborative and grant support paid to his institution from Pacira. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Patient Flow Diagram
Figure 2.
Figure 2.. Postoperative Pain Visual Analog Scale (VAS)
On the VAS, a score of 0 indicates no pain and 100 indicates the worst possible pain. The horizontal line in the middle of each box indicates the median, while the top and bottom borders of the box mark the 75th and 25th percentiles, respectively. The horizontal lines at the top and bottom of each vertical line represent the 95% CIs.
See this image and copyright information in PMC

Comment in

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