title: Continuous intraoperative monitoring of pelvic autonomic nerves during TME to prevent urogenital and anorectal dysfunction in rectal cancer patients (NEUROS): a randomized controlled trial.
abstract: Urinary, sexual and anorectal sequelae are frequent after rectal cancer surgery and were found to be related to intraoperative neurogenic impairment. Neuromonitoring methods have been developed to identify and preserve the complex pelvic autonomic nervous system in order to maintain patients' quality of life. So far no randomized study has been published dealing with the role of neuromonitoring in rectal cancer surgery.
  
  
  
  NEUROS is a prospective two-arm randomized controlled multicenter clinical trial comparing the functional outcome in rectal cancer patients undergoing total mesorectal excision (TME) with and without pelvic intraoperative neuromonitoring (pIONM). A total of 188 patients will be included. Primary endpoint is the urinary function measured by the International Prostate Symptom Score. Secondary endpoints consist of sexual, anorectal functional outcome and safety, especially oncologic safety and quality of TME. Sexual function is assessed in females with the Female Sexual Function Index and in males with the International Index of Erectile Function. For evaluation of anorectal function the Wexner-Vaizey score is used. Functional evaluation is scheduled before radiochemotherapy (if applicable), preoperatively (baseline), before hospital discharge, 3 and 6 months after stoma closure and 12 months after surgery. For assessment of safety adverse events, the rates of positive resection margins and quality of mesorectum are documented.
  
  
  
  This study will provide high quality evidence on the efficacy of pIONM aiming for improvement of functional outcome in rectal cancer patients undergoing TME.
  
  
  
  Clinicaltrials.gov: NCT01585727 . Registration date is 04/25/2012.
authors.affiliation: Department of General, Visceral and Transplant Surgery, University Medicine of the Johannes Gutenberg-University, Mainz, Germany.
authors.forename: D W
authors.initials: DW
authors.lastname: Kauff
authors.affiliation: Interdisciplinary Center for Clinical Trials (IZKS), University Medicine of the Johannes Gutenberg-University, Mainz, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Kronfeld
authors.affiliation: Interdisciplinary Center for Clinical Trials (IZKS), University Medicine of the Johannes Gutenberg-University, Mainz, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Gorbulev
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Wachtlin
authors.affiliation: Department of General, Visceral and Transplant Surgery, University Medicine of the Johannes Gutenberg-University, Mainz, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Lang
authors.affiliation: Department of General, Visceral and Transplant Surgery, University Medicine of the Johannes Gutenberg-University, Mainz, Germany. werner.kneist@unimedizin-mainz.de.
authors.forename: W
authors.initials: W
authors.lastname: Kneist
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001003:Anal Canal / Q000294:innervation; D017776:Autonomic Pathways; D013505:Digestive System Surgical Procedures / Q000009:adverse effects*; D005242:Fecal Incontinence / Q000517:prevention & control; D005260:Female; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D016343:Monitoring, Intraoperative / Q000379:methods*; D059351:Organ Sparing Treatments / Q000379:methods*; D010388:Pelvis / Q000294:innervation*; D059348:Peripheral Nerve Injuries / Q000517:prevention & control; D011446:Prospective Studies; D011788:Quality of Life; D012004:Rectal Neoplasms / Q000601:surgery*; D012735:Sexual Dysfunction, Physiological / Q000517:prevention & control; D016896:Treatment Outcome; D055815:Young Adult
keywords: Autonomic nerves; Fecal incontinence; Intraoperative monitoring; Quality of life; Rectal cancer; Sexual dysfunction; Urinary dysfunction