Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:
• Histologically confirmed rectal cancer
• Surgical resection with TME
• \<90 years old
• Signed informed consent
Locations
Other Locations
Greece
University Hospital of Larissa
RECRUITING
Larissa
Contact Information
Primary
Konstantinos Tepetes, Prof
tepetesk@gmail.com
00302413502804
Backup
Konstantinos Perivoliotis, MD
kperi19@gmail.com
00302413501000
Time Frame
Start Date: 2021-09-19
Estimated Completion Date: 2028-09-19
Participants
Target number of participants: 44
Treatments
Experimental: pIONM
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.
No_intervention: Control
In the control group pIONM will not be performed intraoperatively
Related Therapeutic Areas
Sponsors
Collaborators: General Hospital of Larissa, University of Thessaly
Leads: Larissa University Hospital