Monitoring Pelvic Nerves During Surgery for Rectal Cancer To Improve Urinary and Bowel Function and Quality of Life

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.

Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision