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Intraoperative Monitoring of the Pelvic Autonomic Nerves (NEUROS)

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ClinicalTrials.gov Identifier: NCT01585727
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Werner Kneist, Johannes Gutenberg University Mainz

Tracking Information
First Submitted Date  ICMJE April 25, 2012
First Posted Date  ICMJE April 26, 2012
Last Update Posted Date February 27, 2019
Study Start Date  ICMJE June 2012
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
Urogenital function [ Time Frame: 12 months ]
Increase of IPSS score by at least 5 points observed 12 months after surgery compared to the preoperative IPSS score per patient
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2012)
  • Sexual function (females) [ Time Frame: 12 months ]
    Reduction of FSFI score by at least 8 points 12 months after surgery compared to the preoperative FSFI score per patient.
  • Sexual function (males) [ Time Frame: 12 months ]
    Reduction of IIEF score by at least 15 points 12 months after surgery compared to the preoperative IIEF score per patient.
  • Adverse events [ Time Frame: 12 months ]
    Occurrence of adverse events.
  • Oncological safety [ Time Frame: 12 months ]
    Rates of pCRM-positive specimen (distance of tumour from circumferential resection margin (CRM) ≤ 1mm).
  • Quality of mesorectal excision [ Time Frame: 1 day after the surgery ]
    Macroscopic assessment of the resection specimen.
  • Fecal incontinence [ Time Frame: 12 months ]
    Evaluation of fecal incontinence using the Wexner-Vaizey score
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
  • Sexual function (females) [ Time Frame: 12 months ]
    Reduction of FSFI score by at least 8 points 12 months after surgery compared to the preoperative FSFI score per patient.
  • Sexual function (males) [ Time Frame: 12 months ]
    Reduction of IIEF score by at least 15 points 12 months after surgery compared to the preoperative IIEF score per patient.
  • Adverse events [ Time Frame: 12 months ]
    Occurrence of adverse events.
  • Oncological safety [ Time Frame: 12 months ]
    Rates of pCRM-positive specimen (distance of tumour from circumferential resection margin (CRM) ≤ 1mm).
  • Quality of mesorectal excision [ Time Frame: 1 day after the surgery ]
    Macroscopic assessment of the resection specimen.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraoperative Monitoring of the Pelvic Autonomic Nerves
Official Title  ICMJE Continuous Intraoperative Monitoring of the Pelvic Autonomic Nerves During Total Mesorectal Excision (TME) for the Prevention of Urogenital and Anorectal Dysfunction in Patients With Rectal Cancer.
Brief Summary

One of the major problems of rectal cancer surgery is pelvic autonomic nerve damage, which is the main cause of urogenital dysfunction influencing postoperative quality of life. Costs for diagnostics and treatment of short and long-term urogenital dysfunction are immense. Varying degrees of urogenital dysfunction are found in up to 32% and 55% of patients with rectal cancer despite potentially nerve-sparing total mesorectal excision (TME).

The study will examine the impact of a newly developed continuous monitoring device for preservation of urogenital function in patients with TME for rectal cancer. 188 patients will be included in the prospective, randomized, single-blind, parallel group multi-centre trial including two arms (TME with and without intraoperative continuous monitoring of pelvic autonomic nerves). The primary efficacy endpoint is the change in urinary function measured by International Prostate Function Score (IPSS) 12 months after surgery. Genital functions measured as secondary endpoints. The application of the continuous intraoperative neuromonitoring device could enhance the objective intraoperative confirmation of pelvic nerve sparing surgery. The investigators hypothesis is that the use of his device minimizes the risk of postoperative urogenital dysfunction in patients with TME for rectal cancer. An enormous reduction of treatment costs is to be expected.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Rectal Cancer
Intervention  ICMJE
  • Procedure: TME
    Total mesorectal excision
  • Procedure: Neuromonitoring
    Intraoperative neuromonitoring of pelvic autonomic nerves.
Study Arms  ICMJE
  • Experimental: TME with neuromonitoring
    Total mesorectal excision with intraoperative neuromonitoring of pelvic autonomic nerves.
    Interventions:
    • Procedure: TME
    • Procedure: Neuromonitoring
  • Active Comparator: TME without neuromontoring
    Total mesorectal excision without intraoperative neuromonitoring of pelvic autonomic nerves.
    Intervention: Procedure: TME
Publications * Kauff DW, Kronfeld K, Gorbulev S, Wachtlin D, Lang H, Kneist W. 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 May 21;16:323. doi: 10.1186/s12885-016-2348-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2012)
188
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • informed consent
  • histologically confirmed carcinoma of the rectum (≤ 16 cm from anal verge)
  • fit for radical surgery
  • total mesorectal excision
  • age 18-80 years

Exclusion Criteria:

  • history of operation of the urinary tract (e.g. prostatectomy)
  • pacemaker
  • emergency operation
  • multivisceral resection in the pelvis
  • partial mesorectal excision
  • eligibility for local excision (TEM, intestinal wall resection)
  • ongoing infection or sepsis
  • severe untreated physical or mental impairment
  • pregnancy or breastfeeding
  • women of childbearing potential who are not using a highly effective birth control method
  • missing preoperative data on urogenital or anorectal function
  • simultaneous participation in another clinical trial
  • previous participation in this clinical trial
  • lack of cooperation with the trial procedure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01585727
Other Study ID Numbers  ICMJE 2007-012
KN 930/1-1 ( Other Grant/Funding Number: German Research Foundation (DFG) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Werner Kneist, Johannes Gutenberg University Mainz
Study Sponsor  ICMJE Johannes Gutenberg University Mainz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Werner Kneist, Univ.-Prof. Department of Visceral and Abdominal Surgery, University Medical Center Mainz
PRS Account Johannes Gutenberg University Mainz
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP