Intraoperative Monitoring of the Pelvic Autonomic Nerves

Rectal Cancer Clinical Trial

— NEUROS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585727
• Other study ID #: 2007-012
• Secondary ID: KN 930/1-1
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• TME
Total mesorectal excision
• TME
Total mesorectal excision
• Neuromonitoring
Intraoperative neuromonitoring of pelvic autonomic nerves.

Locations

Country	Name	City	State
Germany	Department of General and Visceral Surgery, University Medical Center Mainz	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sexual function (females)	Reduction of FSFI score by at least 8 points 12 months after surgery compared to the preoperative FSFI score per patient.	12 months
Secondary	Sexual function (males)	Reduction of IIEF score by at least 15 points 12 months after surgery compared to the preoperative IIEF score per patient.	12 months
Secondary	Adverse events	Occurrence of adverse events.	12 months
Secondary	Oncological safety	Rates of pCRM-positive specimen (distance of tumour from circumferential resection margin (CRM) = 1mm).	12 months
Secondary	Quality of mesorectal excision	Macroscopic assessment of the resection specimen.	1 day after the surgery
Secondary	Fecal incontinence	Evaluation of fecal incontinence using the Wexner-Vaizey score	12 months