Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision

NCT04949646 | Recruiting

• 1 other identifier: PelIONM
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research protocol is the evaluation of the improvement of the anorectal and urogenital urinary function, alongside the postoperative quality of life after the application of pIONM in patients submitted to TME for rectal cancer.

Conditions

Rectal Neoplasms

Keywords

intraoperative; neuromonitoring; pelvic; autonomous; total; mesorectal; excision

Outcome Measures

Primary Outcomes (1)

• Change in the quality of life of the patient at 3 months postoperatively, based on the SF-36 questionnaire

  Change in the quality of life of the patient, at 3 months postoperatively, compared to the respective preoperative measurements, based on the Short Form 36 (SF-36) questionnaire SF-36: Short Form Survey Minimum Value: 0 Maximum Value: 100 Higher scores indicate a better outcome

  Preoperatively, 3 months postoperatively

Secondary Outcomes (24)

• Operative time

  Intraoperative period

• Intraoperative bleeding

  Intraoperative period

• Postoperative discharge time

  Maximum time frame 15 days postoperatively

• Postoperative complications

  1 month postoperatively

• Negative resection margin

  1 month postoperatively

Study Arms (2)

pIONM

EXPERIMENTAL

In the experimental group pIONM will be performed intraoperatively. For the implementation of pIONM, a special device, that allows simultaneous monitoring of sphincter signals and bladder manometry, will be introduced. This device will employ the placement of a bipolar electrode in the internal and external anal sphincter. Moreover, another electrode will be placed on the surrounding tissues. For bladder manometry, the catheter will be connected to the pressure sensor, and subsequently to the pIONM monitor. Intraoperatively, depending on the approach (open or laparoscopic), the respective bipolar stimulator will be used. Prior to the initiation of pIONM, urinary bladder will be drained and filled with 200 ml R/L. The pIONM parameters will be the following: 1-25 milliampere current, 30 Hz frequency and 200 μs monophasic pulses.

Other: Pelvic Intraoperative Neuromonitoring

Control

NO INTERVENTION

In the control group pIONM will not be performed intraoperatively

Interventions

Pelvic Intraoperative Neuromonitoring OTHER

Pelvic Intraoperative Neuromonitoring (pIONM) allows mapping of the pelvic autonomous plexus during total mesorectal excision (TME).

pIONM

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed rectal cancer
• Surgical resection with TME
• \<90 years old
• Signed informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Larissa University Hospital: lead
• General Hospital of Larissa: collaborator
• University of Thessaly: collaborator

Study Sites (1)

University Hospital of Larissa

Larissa, 41110, Greece

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Konstantinos Tepetes, Prof

  Department of Surgery, University Hospital of Larissa

  STUDY DIRECTOR

• Konstantinos Perivoliotis, MD

  Department of Surgery, University Hospital of Larissa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantinos Tepetes, Prof

CONTACT

00302413502804; tepetesk@gmail.com

Konstantinos Perivoliotis, MD

CONTACT

00302413501000; kperi19@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be blinded regarding the allocation group. Blinding will not exist at the level of the surgeon, the anaesthesiologist, and the investigator responsible for the data recording
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Perivoliotis Konstantinos, Principal Investigator

Model Details: The study will employ a prospective, parallel randomized-controlled design

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 2, 2021
• Study Start: September 19, 2021
• Primary Completion (Estimated): September 19, 2027
• Study Completion (Estimated): September 19, 2028
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)