Intraoperative Monitoring of the Pelvic Autonomic Nerves

Not Applicable

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: TME; Procedure: Neuromonitoring

• Registration Number: NCT01585727
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-25
• Study First Posted: 2012-04-26
• Study Start: 2012-06
• Primary Completion: 2018-06
• Study Completion: 2018-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TME without neuromontoring	TME	Total mesorectal excision without intraoperative neuromonitoring of pelvic autonomic nerves.
TME with neuromonitoring	TME	Total mesorectal excision with intraoperative neuromonitoring of pelvic autonomic nerves.
TME with neuromonitoring	Neuromonitoring	Total mesorectal excision with intraoperative neuromonitoring of pelvic autonomic nerves.

Primary Outcome Measures

Name	Time	Method
Urogenital function	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 Outcome Measures

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

Trial Locations

Locations (1)

Department of General and Visceral Surgery, University Medical Center Mainz; 🇩🇪 Mainz, Germany