Pelvic Intraoperative Neuromonitoring Prevents Dysfunction in Patients With Rectal Cancer: Results From a Multicenter, Randomized, Controlled Clinical Trial of a NEUROmonitoring System (NEUROS).
Journal
Annals of surgery
ISSN: 1528-1140
Titre abrégé: Ann Surg
Pays: United States
ID NLM: 0372354
Informations de publication
Date de publication:
01 04 2023
01 04 2023
Historique:
pubmed:
1
10
2022
medline:
14
3
2023
entrez:
30
9
2022
Statut:
ppublish
Résumé
This 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. High-level evidence from clinical trials is required to clarify the benefits of pIONM. NEUROS 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. The 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. pIONM is safe and has the potential to improve functional outcomes in rectal cancer patients undergoing TME.
Sections du résumé
OBJECTIVE
This 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.
BACKGROUND
High-level evidence from clinical trials is required to clarify the benefits of pIONM.
METHODS
NEUROS 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.
RESULTS
The 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.
CONCLUSION
pIONM is safe and has the potential to improve functional outcomes in rectal cancer patients undergoing TME.
Identifiants
pubmed: 36177851
doi: 10.1097/SLA.0000000000005676
pii: 00000658-202304000-00026
pmc: PMC9994806
doi:
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e737-e744Informations de copyright
Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.
Déclaration de conflit d'intérêts
W.K., D.W.K., and H.L. are involved in patents, as part of the university service inventions for pIONM (DE 10 2010 019 796 B4; EP 2589410 B1). The remaining authors report no conflicts of interest.
Références
Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery-the clue to pelvic recurrence? Br J Surg. 1982;69:613–616.
Bregni G, Akin Telli T, et al. Grey areas and evidence gaps in the management of rectal cancer as revealed by comparing recommendations from clinical guidelines. Cancer Treat Rev. 2020;82:1019–1030.
German Cancer Society, German Cancer Aid, AWMF. Leitlinienprogramm Onkologie (Deutsche Krebsgesellschaft, Deutsche Krebshilfe, AWMF): S3-Leitlinie Kolorektales Karzinom, Langversion 2.1,2019, AWMF Registrierungsnummer: 021/007OL. Available at: http://www.leitlinienprogramm-onkologie.de/leitlinien/kolorektales-karzinom/ . Accessed February 15, 2021.
Nocera F, Angehrn F, von Flüe M, et al. Optimising functional outcomes in rectal cancer surgery. Langenbecks Arch Surg. 2021;406:233–250.
Valentini V, Aristei C, Glimelius B, et al. Multidisciplinary Rectal Cancer Management: 2nd European Rectal Cancer Consensus Conference (EURECA-CC2). Radiother Oncol. 2009;92:148–163.
Hanna NN, Guillem J, Dosoretz S, et al. Intraoperative parasympathetic nerve stimulation with tumescence monitoring during total mesorectal excision for rectal cancer. J Am Coll Surg. 2002;195:506–512.
da Silva GM, Zmora O, Börjesson L, et al. The efficacy of a nerve stimulator (CaverMap) to enhance autonomic nerve identification and confirm nerve preservation during total mesorectal excision. Dis Colon Rectum. 2004;47:2032–2038.
Kneist W, Heintz A, Junginger T. Intraoperative identification and neurophysiologic parameters to verify pelvic autonomic nerve function during total mesorectal excision for rectal cancer. J Am Coll Surg. 2004;198:59–66.
Kneist W, Kauff DW, Juhre V, et al. Is intraoperative neuromonitoring associated with better functional outcome in patients undergoing open TME? Results of a case-control study. Eur J Surg Oncol. 2013;39:994–999.
Kauff DW, Lang H, Kneist W. Risk factor analysis for newly developed urogenital dysfunction after total mesorectal excision and impact of pelvic intraoperative neuromonitoring—a prospective 2-year follow-up study. J Gastrointest Surg. 2017;21:1038–1047.
Kauff DW, Roth YDS, Bettzieche RS, et al. Fecal incontinence after total mesorectal excision for rectal cancer-impact of potential risk factors and pelvic intraoperative neuromonitoring. World J Surg Oncol. 2020;18:12.
Fang JF, Wei B, Zheng ZH, et al. Effect of intra-operative autonomic nerve stimulation on pelvic nerve preservation during radical laparoscopic proctectomy. Colorectal Dis. 2015;17:O268–O276.
Wałęga P, Romaniszyn M, Wałęga M, et al. Intraoperative neuromonitoring of hypogastric plexus branches during surgery for rectal cancer - preliminary report. Pol Przegl Chir. 2017;89:69–72.
Zhou MW, Huang XY, Chen ZY, et al. Intraoperative monitoring of pelvic autonomic nerves during laparoscopic low anterior resection of rectal cancer. Cancer Manag Res. 2018;11:411–417.
Samara AA, Baloyiannis I, Perivoliotis K, et al. Intraoperative neuromonitoring in rectal cancer surgery: a systematic review and meta-analysis. Int J Colorectal Dis. 2021;36:1385–1394.
Sedrakyan A, Campbell B, Merino JG, et al. IDEAL-D: a rational framework for evaluating and regulating the use of medical devices. BMJ. 2016;353:i2372.
Haim N, Wexner SD. Rectal cancer-associated urinary dysfunction: a review. Curr Bladder Dysfunct Rep. 2015;10:118–124.
Kauff DW, Kronfeld K, Gorbulev S, et al. Continuous intraoperative monitoring of pelvic autonomic nerves during TME to prevent urogenital and anorectal dysfunction in rectal cancer patients (NEUROS): a randomized controlled trial. BMC Cancer. 2016;16:323.
Jayne D, Pigazzi A, Marshall H, et al. Effect of robotic-assisted vs conventional laparoscopic surgery on risk of conversion to open laparotomy among patients undergoing resection for rectal cancer: The ROLARR randomized clinical trial. JAMA. 2017;318:1569–1580.
Possover M, Quakernack J, Chiantera V. The LANN technique to reduce postoperative functional morbidity in laparoscopic radical pelvic surgery. J Am Coll Surg. 2005;201:913–917.
Schuler R, Goos M, Langer A, et al. A new method of intraoperative pelvic neuromonitoring: a preclinical feasibility study in a porcine model. Sci Rep. 2022;12:3696.
Kauff DW, Wachter N, Bettzieche R, et al. Electrophysiology-based quality assurance of nerve-sparing in laparoscopic rectal cancer surgery: Is it worth the effort? Surg Endosc. 2016;30:4525–4532.
Lange MM, Martz JE, Ramdeen B, et al. Long-term results of rectal cancer surgery with a systematical operative approach. Ann Surg Oncol. 2013;20:1806–1815.
Andersson J, Abis G, Gellerstedt M, et al. Patient-reported genitourinary dysfunction after laparoscopic and open rectal cancer surgery in a randomized trial (COLOR II). Br J Surg. 2014;101:1272–1279.
Grama F, Aslan D, Burcos T, et al. Evaluation of the male sexual and urinary functions after open rectal cancer surgery—a questionnaires based study. Arch Balk Med Union. 2015;50:9–17.
Costanzi A, Rigamonti L, Mari GM, et al. A prospective video-controlled study of genito-urinary disorders in 35 consecutive laparoscopic TMEs for rectal cancer. Surg Endosc. 2015;29:1721–1728.
Skinner SA. Pelvic autonomic neuromonitoring: present reality, future prospects. J Clin Neurophysiol. 2014;31:302–312.
Flebbe H, Beham AW, Schüler P, et al. Stellenwert des intraoperativen Neuromonitorings in der roboterassistierten Rektumchirurgie. Zentralbl Chir. 2018;143:215–219.
Schiemer JF, Zimniak L, Grimminger P, et al. Robot-guided neuromapping during nerve-sparing taTME for low rectal cancer (Status of intraoperative neuromonitoring in robot-assisted rectal surgery). Int J Colorectal Dis. 2018;33:1803–1805.
Hawkins AT, Rothman RL, Geiger TM, et al. Patient-reported outcome measures in colon and rectal surgery: a systematic review and quality assessment. Dis Colon Rectum. 2020;6:1156–1167.