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

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.

Conflict of interest statement

Conflict of Interest Disclosures: Drs Petro, Zolin, Krpata, and Alkhatib reported grants from Intuitive Surgical during the conduct of the study. Dr Rosen reported personal fees from AHSQC and grants from Intuitive during the conduct of the study. Dr Prabhu reported grants and personal fees from Intuitive Surgical and personal fees from Verb Surgical during the conduct of the study and personal fees from BD (formerly Bard) and Medtronic outside the submitted work.

Figures

Figure 1.. CONSORT Flow Diagram

aThirty-five patients had hernia-specific quality of life (HerQLes) and Patient-Reported Outcomes Measurement Information System (PROMIS) scores within window. However, only 34 patients had Numerical Rating Scale (NRS) scores. IPOM indicates intraperitoneal onlay mesh; PACU, postanesthesia care unit; POD, postoperative day.

Figure 2.. Sequential Operative Times for Robotic Cases

Median operative time in minutes (surgeon A, 142; surgeon B, 147; P = .51).