• Annals of surgery · Apr 2023

    Randomized Controlled Trial Multicenter Study

    Pelvic Intraoperative Neuromonitoring Prevents Dysfunction in Patients with Rectal Cancer: Results from a Multicenter, Randomized, Controlled Clinical Trial of a NEUROmonitoring System (NEUROS).

    • Werner Kneist, Michael Ghadimi, Norbert Runkel, Thomas Moesta, Stephan Coerper, Claudia Benecke, Daniel W Kauff, Stephan Gretschel, Ines Gockel, Boris Jansen-Winkeln, Hauke Lang, Stanislav Gorbulev, Christian Ruckes, Kai Kronfeld, and NEUROS Study Group.
    • Department of General and Visceral Surgery, St. Georg Hospital Eisenach GmbH, Eisenach, Germany.
    • Ann. Surg. 2023 Apr 1; 277 (4): e737e744e737-e744.

    ObjectiveThis NEUROmonitoring System (NEUROS) trial assessed whether pelvic intraoperative neuromonitoring (pIONM) could improve urogenital and ano-(neo-)rectal functional outcomes in patients who underwent total mesorectal excisions (TMEs) for rectal cancer.BackgroundHigh-level evidence from clinical trials is required to clarify the benefits of pIONM.MethodsNEUROS was a 2-arm, randomized, controlled, multicenter clinical trial that included 189 patients with rectal cancer who underwent TMEs at 8 centers, from February 2013 to January 2017. TMEs were performed with pIONM (n=90) or without it (control, n=99). The groups were stratified according to neoadjuvant chemoradiotherapy and sex, with blocks of variable length. Data were analyzed according to a modified intention-to-treat protocol. The primary endpoint was a urinary function at 12 months after surgery, assessed with the International Prostate Symptom Score, a patient-reported outcome measure. Deterioration was defined as an increase of at least 5 points from the preoperative score. Secondary endpoints were sexual and anorectal functional outcomes, safety, and TME quality.ResultsThe intention-to-treat analysis included 171 patients. Marked urinary deterioration occurred in 22/171 (13%) patients, with significantly different incidence between groups (pIONM: n=6/82, 8%; control: n=16/89, 19%; 95% confidence interval, 12.4-94.4; P =0.0382). pIONM was associated with better sexual and ano-(neo)rectal function. At least 1 serious adverse event occurred in 36/88 (41%) in the pIONM group and 53/99 (54%) in the control group, none associated with the study treatment. The groups had similar TME quality, surgery times, intraoperative complication incidence, and postoperative mortality.ConclusionpIONM is safe and has the potential to improve functional outcomes in rectal cancer patients undergoing TME.Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

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