Intraoperative Monitoring of the Pelvic Autonomic Nerves (NEUROS)

February 26, 2019 updated by: Werner Kneist, Johannes Gutenberg University Mainz

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany
        • Department of General and Visceral Surgery, University Medical Center Mainz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
Adverse events
Time Frame: 12 months
Occurrence of adverse events.
12 months
Oncological safety
Time Frame: 12 months
Rates of pCRM-positive specimen (distance of tumour from circumferential resection margin (CRM) ≤ 1mm).
12 months
Quality of mesorectal excision
Time Frame: 1 day after the surgery
Macroscopic assessment of the resection specimen.
1 day after the surgery
Fecal incontinence
Time Frame: 12 months
Evaluation of fecal incontinence using the Wexner-Vaizey score
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Werner Kneist, Univ.-Prof., Department of Visceral and Abdominal Surgery, University Medical Center Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

April 25, 2012

First Submitted That Met QC Criteria

April 25, 2012

First Posted (Estimate)

April 26, 2012

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-012
  • KN 930/1-1 (Other Grant/Funding Number: German Research Foundation (DFG))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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