Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006463

Trial Description

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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.

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Trial Acronym

NEUROS

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006463
  •   2015/04/14
  •   2012/04/25
  •   yes
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Secondary IDs

  •   NCT01585727  (ClinicalTrials.gov)
  •   2007-012  (Johannes Gutenberg University Mainz)
  •   KN 930/1-1 
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Health Condition or Problem studied

  •   Rectal Cancer
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Procedure: TME
  •   Procedure: TME
  •   Procedure: Neuromonitoring
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
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Primary Outcome

- 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

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2012/06/30
  •   188
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional 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

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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

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Addresses

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    • Johannes Gutenberg University Mainz
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    • Department of Visceral and Abdominal Surgery, University Medical Center Mainz
    • Werner Kneist, Univ.-Prof. 
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    • Werner Kneist, Univ.-Prof. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.