Intraoperative Monitoring of the Pelvic Autonomic Nerves
NEUROS
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.
2 other identifiers
interventional
188
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2012
CompletedFirst Posted
Study publicly available on registry
April 26, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 27, 2019
February 1, 2019
6 years
April 25, 2012
February 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urogenital function
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 Outcomes (6)
Sexual function (females)
12 months
Sexual function (males)
12 months
Adverse events
12 months
Oncological safety
12 months
Quality of mesorectal excision
1 day after the surgery
- +1 more secondary outcomes
Study Arms (2)
TME with neuromonitoring
EXPERIMENTALTotal mesorectal excision with intraoperative neuromonitoring of pelvic autonomic nerves.
TME without neuromontoring
ACTIVE COMPARATORTotal mesorectal excision without intraoperative neuromonitoring of pelvic autonomic nerves.
Interventions
Intraoperative neuromonitoring of pelvic autonomic nerves.
Eligibility Criteria
You may qualify if:
- informed consent
- histologically confirmed carcinoma of the rectum (≤ 16 cm from anal verge)
- fit for radical surgery
- total mesorectal excision
- age 18-80 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of General and Visceral Surgery, University Medical Center Mainz
Mainz, Germany
Related Publications (1)
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.
PMID: 27209237DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Werner Kneist, Univ.-Prof.
Department of Visceral and Abdominal Surgery, University Medical Center Mainz
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior physician, Department of Visceral and Abdominal Surgery
Study Record Dates
First Submitted
April 25, 2012
First Posted
April 26, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2018
Study Completion
December 1, 2018
Last Updated
February 27, 2019
Record last verified: 2019-02