Robotic eTEP versus IPOM evaluation: the REVEAL multicenter randomized clinical trial

Autor: Clayton C, Petro, Katherine C, Montelione, Samuel J, Zolin, David B, Renton, Jonathan P, Yunis, Michael P, Meara, Adele, Costanzo, Kayla, Diaz, Kristen, McKenzie, Melanie, Wilber, Tamela, Fonseca, Chao, Tu, Molly A, Olson, David M, Krpata, Lucas R, Beffa, Ben K, Poulose, Michael J, Rosen, Ajita S, Prabhu
Rok vydání: 2022
Zdroj: Surgical endoscopy.
ISSN: 1432-2218
Popis: For small to medium-sized ventral hernias, robotic intraperitoneal onlay mesh (rIPOM) and enhanced-view totally extraperitoneal (eTEP) repair have emerged as acceptable approaches that each takes advantage of robotic instrumentation. We hypothesized that avoiding mesh fixation in a robotic eTEP repair offers an advantage in early postoperative pain compared to rIPOM.This is a multi-center, randomized clinical trial for patients with midline ventral hernias ≤ 7 cm, who were randomized to rIPOM or robotic eTEP. The primary outcome was pain (0-10) on the first postoperative day. Secondary outcomes included same-day discharge, length of stay, opioid consumption, quality of life, surgeon workload, and cost.Between November 2019 and November 2021, 100 patients were randomized (49 rIPOM, 51 eTEP) among 5 surgeons. Pain on the first postoperative day [median (IQR): 5 (4-6) vs. 5 (3.5-7), p = 0.66] was similar for rIPOM and eTEP, respectively, a difference maintained following adjustments for surgeon, operative time, baseline pain, and patient co-morbidities (difference 0.28, 95% CI - 0.63 to 1.19, p = 0.56). No differences in pain on the day of surgery, 7, and 30 days after surgery were identified. Same-day discharge, length of stay, opioid consumption, and 30-day quality of life were also comparable, though rIPOM required less surgeon workload (p 0.001), shorter operative time [107 (86-139) vs. 165 (129-212) min, p 0.001], and resulted in fewer surgical site occurrences (0 vs. 8, p = 0.004). The total direct costs for rIPOM and eTEP were comparable [$8282 (6979-11835) vs. $8680 (7550-10282), p = 0.52] as the cost savings for eTEP attributable to mesh use [$442 (434-485) vs. $69 (62-76), p = 0.0001] were offset by increased expenses for operative time [$669 (579-861) vs. $1075 (787-1367), p 0.0001] and use of more robotic equipment [$760 (615-933) vs. $946 (798-1203), p = 0.001].The avoidance of fixation in a robotic eTEP repair did not reveal a benefit in postoperative pain to offset the shorter operative time and surgeon workload offered by rIPOM.
Databáze: OpenAIRE