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Spots Global Cancer Trial Database for Intraoperative Monitoring of the Pelvic Autonomic Nerves

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Trial Identification

Brief Title: 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 ID: NCT01585727

Conditions

Rectal Cancer

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Werner Kneist, Univ.-Prof.

Affiliation: Department of Visceral and Abdominal Surgery, University Medical Center Mainz

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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