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

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Abstract

Background

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.

Methods

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.

Results

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].

Conclusion

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.

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Funding

Funding was provided by Society of American Gastrointestinal and Endoscopic Surgeons (Grant No. SAGES 2020 Robotic Research Grant Recipient) and Americas Hernia Society Foundation (Grant No. 2020 ACHQC Foundation Research Grant).

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Authors and Affiliations

  1. Department of Surgery, Center for Abdominal Core Health, Lerner College of Medicine, Cleveland Clinic Foundation, 9500 Euclid Ave. A-100, Cleveland, OH, 44195, USA

    Clayton C. Petro, Katherine C. Montelione, Samuel J. Zolin, Adele Costanzo, David M. Krpata, Lucas R. Beffa, Michael J. Rosen & Ajita S. Prabhu

  2. Department of Surgery, Center for Abdominal Core Health, The Ohio State University Wexner Medical Center, Columbus, OH, USA

    David B. Renton, Michael P. Meara, Kayla Diaz & Ben K. Poulose

  3. Center for Hernia Repair, Sarasota Memorial Hospital, Sarasota, FL, USA

    Jonathan P. Yunis, Kristen McKenzie, Melanie Wilber & Tamela Fonseca

  4. Department of Statistics, Cleveland Clinic Foundation, Cleveland, OH, USA

    Chao Tu

  5. Department of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA

    Molly A. Olson

Authors
  1. Clayton C. Petro
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  2. Katherine C. Montelione
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Corresponding author

Correspondence to Clayton C. Petro.

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Disclosures

Clayton C. Petro has received societal research grants from the American Hernia Society and SAGES for this trial. Separate societal research grants from the American Hernia Society and Central Surgical Associations were received for other projects. Katherine C. Montelione, MD, MS—No Disclosures. Samuel J. Zolin, MD—No Disclosures. David B. Renton, MD FACS—No Disclosures. Jonathan P. Yunis, MD FACS—No Disclosures. Michael P. Meara, MD FACS—Is a paid speaker for Intuitive Surgical. Adele Costanzo, RN—No Disclosures. Kayla Diaz, MCR CCRP—No Disclosures. Kristen McKenzie, BSN RN—No Disclosures. Melanie Wilber, LPN—No Disclosures. Tamela Fonseca, MSN, RN, CCRC, NE-BC—No Disclosures. Chao Tu, MS—No Disclosures. Molly A. Olson, MS—No Disclosures. The ACHQC has contracted with Weill Cornell Medicine to provide biostatistical support for ACHQC projects. The work provided for this manuscript was performed under the umbrella of the Weill Cornell Medicine and ACHQC collaboration plan. David M. Krpata, MD FACS—No Disclosures. Lucas R. Beffa, MD FACS—Is a paid speaker for Intuitive Surgical. Ben K. Poulose, MD FACS—Has received research support from BD and Advanced Medical Solutions. He currently receives salary support from the Abdominal Core Health Quality Collaborative (ACHQC) as the Director for Quality and Outcomes. Michael J. Rosen, MD FACS—Receives salary support for role of medical director of the ACHQC, and is a board member of Ariste Medical. Ajita S. Prabhu, MD FACS—Dr. Prabhu reports research grants from Intuitive Surgical and serving as a consultant for CMR Surgical and Verb Surgical.

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Petro, C.C., Montelione, K.C., Zolin, S.J. et al. Robotic eTEP versus IPOM evaluation: the REVEAL multicenter randomized clinical trial. Surg Endosc 37, 2143–2153 (2023). https://doi.org/10.1007/s00464-022-09722-9

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