Five-year outcomes of the PROVE-IT randomized controlled trial: Patient-Reported Outcomes of Robotic vs. Laparoscopic Ventral Hernia Repair with Intraperitoneal Mesh

Background The Patient-Reported Outcomes of Robotic vs. Laparoscopic Ventral Hernia Repair with Intraperitoneal Mesh (PROVE-IT) randomized controlled trial previously demonstrated comparable pain at 1 year postoperatively between laparoscopic (lapIPOM) and robotic (rIPOM) approaches, although with potential differences in quality of life and recurrence. We aim to report 5-year follow-up of the PROVE-IT trial. Methods All patients previously enrolled in PROVE-IT, a registry-based randomized controlled trial published in October 2020, were reviewed. Outcomes including hernia-specific quality of life (Hernia-Related Quality-of-Life Survey [HerQLes]), pain intensity (Patient-Reported Outcomes Measurement Information System [PROMIS 3a]), patient-reported bulging (Hernia Recurrence Inventory [HRI]), clinical hernia recurrences, and reoperations were analyzed. Results Median time to clinical follow-up was 65 months [interquartile range (IQR) 56, 71]. Patient-reported outcomes were obtained for 49 of 75 patients (26 lapIPOM, 23 rIPOM). Clinical follow-up (physical exam and/or cross-sectional imaging) was completed for 64 of 75 patients (30 lapIPOM, 34 rIPOM). Median HerQLes and PROMIS 3a scores were 92 [IQR 68, 99] and 31 [IQR 31, 31] in the laparoscopic group and 92 [IQR 78, 95] and 31 [IQR 31, 31] in the robotic group ( p = 0.91 and p = 0.86, respectively). Patient-reported bulging rates were 27% (lapIPOM) and 30% (rIPOM), p = 1.00. Clinical recurrence rates were 10% ( n = 3) in the laparoscopic group and 24% ( n = 8) in the robotic group, p = 0.27. Of fourteen abdominal reoperations (8 lapIPOM, 6 rIPOM, p = 0.57), two laparoscopic patients required elective reoperation for recurrence and no patients required mesh excision. There were no reoperations for recurrence in the robotic group. Conclusions In this exploratory analysis, postoperative quality of life, pain intensity, recurrence, and reoperation rates were found to be comparable between laparoscopic and robotic IPOMs at 5 years.