Clinical Trial: Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Exploratory Study for Evaluating the Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors (FUSION Trial V)

Brief Summary:

Although nerve-sparing surgery has been introduced for female patients with the pelvic tumors, its success rate depends on operators. To achieve consistency of surgical procedure, It is necessary to adopt pelvic autonomic nerve monitoring technique.

The Aims of this study is

  1. Development of pelvic autonomic nerve monitoring system (PAMS I) by using urodynamic system.
  2. Evaluation of autonomic nerve sparing by intraoperative monitoring with PAMS I
  3. Evaluating the efficacy of PAMS I by intraoperative neurophysiological monitoring (IOM)

Detailed Summary:

After surgery for pelvic tumor, most of patients complain voiding dysfunction, defecation dysfunction and sexual dysfunction which lead to decrease quality of life. Recently, nerve-sparing surgery has been introduced. But it is difficult to establish standard surgical procedure for nerve-sparing. And it is the concern that performing nerve sparing surgery may reduce radicality of surgery which influence prognosis.

Through pelvic autonomic nerve monitoring system (PAMS I), this trial is expected to raise the possibility of nerve-sparing with maintaining radicality of surgery.

Pressure sensor of PAMS I and needle prove of IOM are very thin and these instruments have been used clinically. Taking this into consideration, additional risk by nerve monitoring is considered to be minimal.


Sponsor: Seoul National University Hospital

Current Primary Outcome: Evaluating efficacy of PAMS I by comparison with IOM [ Time Frame: Intraoperative ]

Comparision pressure change on PAMS I with nerve conduction on IOM

i) PAMS I (+) & IOM (+): nerve-sparing

ii) PAMS I (-) & IOM (-): nerve damage

iii) PAMS I (+) & IOM (-) or PAMS I (-) & IOM (+): intermediate



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluation of Quality of life. [ Time Frame: Preoperative, 3 months after surgery ]
    Voiding/Defecation/Sexual function
  • Time period for recovering normal voiding function [ Time Frame: postoperative (up to 6 month) ]
    Check residual urine. Keep CIC until residual urine < 100cc
  • Urodynamic test [ Time Frame: Preoperative, 3 months after surgery ]
  • Anorectal manometry [ Time Frame: Preoperative, 3 months after surgery ]


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: October 17, 2016
Date Started: July 2015
Date Completion:
Last Updated: October 30, 2016
Last Verified: October 2016