Monitoring pelvic nerves during rectal cancer surgery
Official title: Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision
Run by Larissa University Hospital · NCT04949646 · Data updated 2026-11-12
This study is testing if using nerve monitoring during rectal cancer surgery can help patients avoid problems like incontinence and improve their quality of life after the operation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 44 (estimated) |
| Sponsor | Larissa University Hospital Academic / other |
| Locations | 1 site (Larissa) |
| Status | Recruiting |
| Started | September 19, 2021 |
| Main results expected | September 19, 2027 |
| Study ends | September 19, 2028 |
| Registry record updated | September 4, 2025 |
| Trial ID | NCT04949646 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with histologically confirmed rectal cancer who are scheduled for total mesorectal excision and are under 90 years old.
✕Probably not a fit
Patients who may not benefit include those undergoing emergency operations, those with pacemakers, or those with significant physical or mental impairments.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the use of pelvic intraoperative neuromonitoring (pIONM) during total mesorectal excision (TME) for rectal cancer. The aim is to improve postoperative anorectal and urogenital function, as well as overall quality of life for patients. By monitoring the pelvic autonomous nerve plexus during surgery, the researchers hope to reduce the incidence of complications such as fecal and urinary incontinence. The study includes patients with histologically confirmed rectal cancer who are undergoing surgical resection with TME.
Why it matters
Potential benefit: If successful, this approach could significantly enhance postoperative quality of life by reducing the risk of urogenital and anorectal dysfunction.
How similar studies have gone: While the use of intraoperative neuromonitoring is gaining traction, this specific application in TME for rectal cancer is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed rectal cancer * Surgical resection with TME * \<90 years old * Signed informed consent Exclusion Criteria: * 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
Where it's running
-
University Hospital of Larissa
Larissa, Greece Recruiting
Study contacts
- Principal investigator: Konstantinos Perivoliotis, MD — Department of Surgery, University Hospital of Larissa
- Study coordinator: Konstantinos Tepetes, Prof
- Email: tepetesk@gmail.com
- Phone: 00302413502804
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.