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NCT Number: NCT01585727

Intraoperative Monitoring of the Pelvic Autonomic Nerves

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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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of General and Visceral Surgery, University Medical Center Mainz

Mainz, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TME

Procedure

Total mesorectal excision

Neuromonitoring

Procedure

Intraoperative neuromonitoring of pelvic autonomic nerves.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study 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.

Acronym: NEUROS

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Apr 26, 2012
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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