Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
Healthy Volunteers
ID04949646

Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision for Rectal Cancer

Led by Larissa University Hospital · Updated on 2025-09-04

44

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

L

Larissa University Hospital

Lead Sponsor

G

General Hospital of Larissa

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the improvement of anorectal and urogenital urinary function as well as postoperative quality of life in patients undergoing Total Mesorectal Excision (TME) for rectal cancer. The study focuses on the effect of intraoperative neuromonitoring of the pelvic autonomous nerves (pIONM) during surgery. Postoperative urogenital and sexual dysfunction and low anterior syndrome (LARS) are common complications after TME, affecting patients' quality of life, and this research aims to assess whether pIONM can help reduce these issues. Participants will be randomly assigned to one of two groups. The experimental group will receive intraoperative neuromonitoring using a special device that simultaneously monitors sphincter signals and bladder pressure. Electrodes will be placed in the internal and external anal sphincters and surrounding tissues, and bladder manometry will be performed through a catheter connected to a pressure sensor and monitor. Stimulation parameters include a current of 1-25 milliamps at 30 Hz frequency. The control group will undergo TME without intraoperative neuromonitoring. Both open and laparoscopic surgical approaches will be used depending on the case. During the study, participants will undergo assessments before surgery and at multiple postoperative time points, including 3 months and up to 24 months. Evaluations include quality of life questionnaires (SF-36), urinary and sexual function questionnaires (IIEF, FSFI, IPSS), and tests measuring bladder capacity, compliance, urinary flow, anal sphincter pressure, and anorectal function. Researchers will monitor operative time, bleeding, complications, hospital discharge time, and local cancer recurrence for up to one year. The primary outcome is the change in quality of life three months after surgery.

CONDITIONS

Brief Title

Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed rectal cancer
  • Scheduled for surgical resection with Total Mesorectal Excision (TME)
  • Age less than 90 years
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Emergency operation
  • Presence of pacemaker
  • Partial mesorectal excision instead of total
  • Sepsis or systemic infection
  • Physical or mental impairment
  • Pregnancy or nursing
  • Insufficient preoperative data for urogenital or anorectal function
  • Lack of compliance with the research process

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and hospital stay up to 15 days postoperatively

Participants undergo total mesorectal excision (TME) surgery, with or without intraoperative neuromonitoring of the pelvic autonomous nerve plexus. During surgery, special monitoring devices may be used to map nerve function. Immediate post-operative care follows surgery.

1 surgical visit plus hospital stay and assessments until discharge

Post-operative Follow-up

Duration - Up to 24 months postoperatively

Participants are monitored for recovery and complications after surgery. Follow-up includes assessments of quality of life, urogenital and anorectal function, and other health measures at multiple timepoints up to 24 months after surgery.

Visits at 2, 3, 6, 12, and 24 months postoperatively

Trial Site Locations

Total: 1 location

1

University Hospital of Larissa

Larissa, Greece, 41110

Actively Recruiting

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Research Team

K

Konstantinos Tepetes, Prof

K

Konstantinos Perivoliotis, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Continuous intraoperative monitoring of autonomic nerves during low anterior rectal resection: an innovative approach for observation of functional nerve integrity in pelvic surgery.

D W Kauff, O Kempski, K P Koch...

https://pubmed.ncbi.nlm.nih.gov/22350611

Risk Factor Analysis for Newly Developed Urogenital Dysfunction after Total Mesorectal Excision and Impact of Pelvic Intraoperative Neuromonitoring-a Prospective 2-Year Follow-Up Study.

Daniel W Kauff, Hauke Lang, Werner Kneist

https://pubmed.ncbi.nlm.nih.gov/28378317

Causes of fecal and urinary incontinence after total mesorectal excision for rectal cancer based on cadaveric surgery: a study from the Cooperative Clinical Investigators of the Dutch total mesorectal excision trial.

Christian Wallner, Marilyne M Lange, Bert A Bonsing...

https://pubmed.ncbi.nlm.nih.gov/18802159

Continuous intraoperative monitoring of pelvic autonomic nerves during TME to prevent urogenital and anorectal dysfunction in rectal cancer patients (NEUROS): a randomized controlled trial.

D W Kauff, K Kronfeld, S Gorbulev...

https://pubmed.ncbi.nlm.nih.gov/27209237

Intraoperative pelvic nerve stimulation performed under continuous electromyography of the internal anal sphincter.

Werner Kneist, Daniel W Kauff, Roman K Rahimi Nedjat...

https://pubmed.ncbi.nlm.nih.gov/20661601

Extracorporeal Stimulation of Sacral Nerve Roots for Observation of Pelvic Autonomic Nerve Integrity: Description of a Novel Methodological Setup.

Tomasz Moszkowski, Daniel W Kauff, Celine Wegner...

https://pubmed.ncbi.nlm.nih.gov/28504930

Online signal processing of internal anal sphincter activity during pelvic autonomic nerve stimulation: a new method to improve the reliability of intra-operative neuromonitoring signals.

D W Kauff, K P Koch, K H Somerlik...

https://pubmed.ncbi.nlm.nih.gov/21087387