Robotic Enhanced-View Totally Extraperitoneal vs Intraperitoneal Onlay Mesh Evaluation: 1-Year Exploratory Outcomes of the REVEAL Randomized Clinical Trial

摘要

BACKGROUND: Patients with small- to medium-sized ventral hernias randomized to robotic enhanced-view totally extraperitoneal (eTEP) or robotic intraperitoneal onlay mesh (rIPOM) previously demonstrated comparable 30-day patient-reported outcomes. Here we report 1-year exploratory outcomes for this multi-center, patient-blinded randomized clinical trial. STUDY DESIGN: Patients with midline ventral hernias 7 cm wide or less undergoing mesh repair were randomized to robotic eTEP or rIPOM. Planned exploratory outcomes at 1 year include pain intensity (using the Patient-Reported Outcomes Measurement Information System [PROMIS 3a]), Hernia-Related Quality of Life Survey (HerQLes) scores, pragmatic hernia recurrence, and reoperation. RESULTS: One hundred randomized patients (51 eTEP, 49 rIPOM) reached a median 12-month follow-up (interquartile range 11 to 13) with 7% lost. After regression analysis adjusting for baseline scores, there was no difference in postoperative pain intensity at 1-year for eTEP compared with rIPOM (odds ratio [OR] 2.1 [95% CI 0.85 to 5.1]; p = 0.11). HerQLes scores were 15 points lower on average (ie less improved) at 1 year after eTEP repairs compared with rIPOM, a difference maintained after regression analysis (OR 0.31 [95% CI 0.15 to 0.67]; p = 0.003). Pragmatic hernia recurrence was 12.2% (6 of 49) for eTEP and 15.9% (7 of 44) for rIPOM (p = 0.834). In the first year, 2 eTEP and 1 rIPOM patients required reoperations related to their index repair (p = 0.82). CONCLUSIONS: Exploratory analyses showed similar outcomes at 1 year in regard to pain, hernia recurrence, and reoperation. Abdominal wall quality of life at 1 year appears to favor rIPOM, and the possibility that an eTEP dissection is less advantageous in that regard should be the subject of future investigation.