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Intraoperative Monitoring of the Pelvic Autonomic Nerves (NEUROS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: TME Procedure: Neuromonitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : June 2012
Actual Primary Completion Date : June 2018
Actual Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: TME with neuromonitoring
Total mesorectal excision with intraoperative neuromonitoring of pelvic autonomic nerves.
Procedure: TME
Total mesorectal excision

Procedure: Neuromonitoring
Intraoperative neuromonitoring of pelvic autonomic nerves.

Active Comparator: TME without neuromontoring
Total mesorectal excision without intraoperative neuromonitoring of pelvic autonomic nerves.
Procedure: TME
Total mesorectal excision




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Adverse events [ Time Frame: 12 months ]
    Occurrence of adverse events.

  4. Oncological safety [ Time Frame: 12 months ]
    Rates of pCRM-positive specimen (distance of tumour from circumferential resection margin (CRM) ≤ 1mm).

  5. Quality of mesorectal excision [ Time Frame: 1 day after the surgery ]
    Macroscopic assessment of the resection specimen.

  6. Fecal incontinence [ Time Frame: 12 months ]
    Evaluation of fecal incontinence using the Wexner-Vaizey score



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585727


Locations
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Germany
Department of General and Visceral Surgery, University Medical Center Mainz
Mainz, Germany
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
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Principal Investigator: Werner Kneist, Univ.-Prof. Department of Visceral and Abdominal Surgery, University Medical Center Mainz
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Werner Kneist, Senior physician, Department of Visceral and Abdominal Surgery, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01585727    
Other Study ID Numbers: 2007-012
KN 930/1-1 ( Other Grant/Funding Number: German Research Foundation (DFG) )
First Posted: April 26, 2012    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Keywords provided by Werner Kneist, Johannes Gutenberg University Mainz:
Rectal cancer
total mesorectal excision
pelvic autonomic nerve preservation
neurostimulation
urogenital function
quality of life
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases