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01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

BMC Cancer 1/2016

Continuous intraoperative monitoring of pelvic autonomic nerves during TME to prevent urogenital and anorectal dysfunction in rectal cancer patients (NEUROS): a randomized controlled trial

Zeitschrift:
BMC Cancer > Ausgabe 1/2016
Autoren:
D. W. Kauff, K Kronfeld, S Gorbulev, D Wachtlin, H Lang, W Kneist
Wichtige Hinweise

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

WK, KK and DW designed the study; DWK, WK, SG; KK and DW wrote the protocol; DW conducted statistical trial planning; SG handled ethics and regulatory affairs; KK and WK prepared the application for funding; DWK and WK wrote the paper draft; SG, KK, DW and HL did the critical review; all authors have approved the final version of the manuscript.

Abstract

Background

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.

Methods/design

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.

Discussion

This study will provide high quality evidence on the efficacy of pIONM aiming for improvement of functional outcome in rectal cancer patients undergoing TME.

Trial registration

Clinicaltrials.gov: NCT01585727. Registration date is 04/25/2012
Literatur
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