Clinical trial NCT01585727: Intraoperative Monitoring of the Pelvic Autonomic Nerves
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: Rectal cancer
total mesorectal excision
pelvic autonomic nerve preservation
neurostimulation
urogenital function
quality of life
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2012-04-26
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Urogenital function
timeFrame: 12 months
Secondary outcomes:
measure: Sexual function (females)
timeFrame: 12 months
measure: Sexual function (males)
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
measure: Oncological safety
timeFrame: 12 months
measure: Quality of mesorectal excision
timeFrame: 1 day after the surgery
measure: Fecal incontinence
timeFrame: 12 months
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of General and Visceral Surgery, University Medical Center Mainz
Study officials:
affiliation: Department of Visceral and Abdominal Surgery, University Medical Center Mainz
name: Werner Kneist, Univ.-Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.