Robotic vs Laparoscopic Ventral Hernia Repair with Intraperitoneal Mesh: 1-Year Exploratory Outcomes of the PROVE-IT Randomized Clinical Trial.

Abstract

Laparoscopic and robotic ventral hernia repair with intraperitoneal mesh have been demonstrated previously to have comparable 30-day outcomes in the PROVE-IT randomized clinical trial. Here we report our 1-year follow-up of enrolled patients to examine exploratory outcomes. All patients enrolled in a previously published, registry-based, randomized trial investigating laparoscopic vs robotic ventral hernia repair with intraperitoneal mesh were reviewed. Several exploratory secondary outcomes were assessed: pain intensity (Patient-Reported Outcomes Measurement Information System [PROMIS 3a]), hernia-specific quality of life (Hernia-Specific Quality of Life Survey [HerQLes]), composite hernia recurrence, and reoperations. A total of 95% (71 of 75) follow-up was achieved: 33 laparoscopic repairs and 38 robotic repairs. Median follow-up time was 12 months [interquartile range 10 to 12 months]. Following regression analysis adjusting for baseline scores, there was no difference in postoperative pain intensity at 1 year (p = 0.94). However, HerQLes scores increased by 12.0 more points following robotic repairs compared to laparoscopic counterparts (95% CI 1.3 to 22.7, p = 0.03). Composite hernia recurrence was 6% (2 of 33) for the laparoscopic cohort and 24% (9 of 38) for the robotic group (p = 0.04). There was no difference in rates of reoperation (p = 0.61). Our exploratory analyses have identified potential differences in quality of life and recurrence, favoring the robotic and laparoscopic approaches, respectively. These findings warrant further study with larger patient cohorts to verify their potential significance.