Intraoperative Monitoring of the Pelvic Autonomic Nerves

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: TME
* Procedure: TME
* Procedure: Neuromonitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TME with neuromonitoring<br>Total mesorectal excision with intraoperative neuromonitoring of pelvic autonomic nerves. | Procedure: TME<br>* Total mesorectal excision<br>Procedure: Neuromonitoring<br>* Intraoperative neuromonitoring of pelvic autonomic nerves.<br>|
| Active Comparator: TME without neuromontoring<br>Total mesorectal excision without intraoperative neuromonitoring of pelvic autonomic nerves. | Procedure: TME<br>* Total mesorectal excision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Adverse events | Occurrence of adverse events. | 12 months | 
| Oncological safety | Rates of pCRM-positive specimen (distance of tumour from circumferential resection margin (CRM) ≤ 1mm). | 12 months | 
| Quality of mesorectal excision | Macroscopic assessment of the resection specimen. | 1 day after the surgery | 
| Fecal incontinence | Evaluation of fecal incontinence using the Wexner-Vaizey score | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal cancer, total mesorectal excision, pelvic autonomic nerve preservation, neurostimulation, urogenital function, quality of life