Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision
Recruiting · NCT04949646 · Interventional (participants receive a specific treatment) · Lead sponsor: Larissa University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Pelvic Intraoperative Neuromonitoring
What this trial is about
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.
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- University Hospital of Larissa - Larissa, Greece