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Original Investigation
October 21, 2020

Patient-Reported Outcomes of Robotic vs Laparoscopic Ventral Hernia Repair With Intraperitoneal Mesh: The PROVE-IT Randomized Clinical Trial

Author Affiliations
  • 1Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, The Cleveland Clinic Foundation, Cleveland Clinic, Cleveland, Ohio
  • 2Lerner Research Institute, Department of Quantitative Health Sciences, The Cleveland Clinic Foundation, Cleveland, Ohio
JAMA Surg. Published online October 21, 2020. doi:10.1001/jamasurg.2020.4569
Key Points

Question  Does robotic ventral hernia repair with intraperitoneal mesh offer a clinical benefit compared with the traditional laparoscopic approach?

Findings  In this single-blinded, randomized clinical trial of 75 patients, no significant difference in pain, complications, quality of life, and hospital length of stay was found. The 52-minute increase in median operative time of the robotic approach incurring additional cost is not countered by a measurable benefit.

Meaning  There is no apparent clinical benefit to the robotic approach when compared with the traditional laparoscopic ventral hernia repair with intraperitoneal mesh.

Abstract

Importance  Despite rapid adoption of the robotic platform for ventral hernia repair with intraperitoneal mesh in the United States, there is no level I evidence comparing it with the traditional laparoscopic approach. This randomized clinical trial sought to demonstrate a clinical benefit to the robotic approach.

Objective  To determine whether robotic approach to ventral hernia repair with intraperitoneal mesh would result in less postoperative pain.

Design, Setting, and Participants  A registry-based, single-blinded, prospective randomized clinical trial at the Cleveland Clinic Center for Abdominal Core Health, Cleveland, Ohio, completed between September 2017 and January 2020, with a minimum follow-up duration of 30 days. Two surgeons at 1 academic tertiary care hospital. Patients with primary or incisional midline ventral hernias of an anticipated width of 7 cm or less presenting in the elective setting and able to tolerate a minimally invasive repair.

Interventions  Patients were randomized to a standardized laparoscopic or robotic ventral hernia repair with fascial closure and intraperitoneal mesh.

Main Outcomes and Measures  The trial was powered to detect a 30% difference in the Numerical Rating Scale (NRS-11) on the first postoperative day. Secondary end points included the Patient-Reported Outcomes Measurement Information System Pain Intensity short form (3a), hernia-specific quality of life, operative time, wound morbidity, recurrence, length of stay, and cost.

Results  Seventy-five patients completed their minimally invasive hernia repair: 36 laparoscopic and 39 robotic. Baseline demographics and hernia characteristics were comparable. Robotic operations had a longer median operative time (146 vs 94 minutes; P < .001). There were 2 visceral injuries in each cohort but no full-thickness enterotomies or unplanned reoperations. There were no significant differences in NRS-11 scores preoperatively or on postoperative days 0, 1, 7, or 30. Specifically, median NRS-11 scores on the first postoperative day were the same (5 vs 5; P = .61). Likewise, postoperative Patient-Reported Outcomes Measurement Information System 3a and hernia-specific quality-of-life scores, as well as length of stay and complication rates, were similar. The robotic platform adds cost (total cost ratio, 1.13 vs 0.97; P = .03), driven by the cost of additional operating room time (1.25 vs 0.85; P < .001).

Conclusions and Relevance  Laparoscopic and robotic ventral hernia repair with intraperitoneal mesh have comparable outcomes. The increased operative time and proportional cost of the robotic approach are not offset by a measurable clinical benefit.

Trial Registration  ClinicalTrials.gov Identifier: NCT03283982

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