Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors (FUSION V)

• ClinicalTrials.gov Identifier: NCT02952183
• Recruitment Status: Unknown
• First Posted: November 2, 2016
• Last Update Posted: November 2, 2016
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Hee Seung Kim, Seoul National University Hospital

Tracking Information

• First Submitted Date: October 17, 2016
• First Posted Date: November 2, 2016
• Last Update Posted Date: November 2, 2016
• Study Start Date: July 2015
• Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 30, 2016)

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 Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 30, 2016)

• 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 Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors
• 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 Description

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label)

Condition

• Cervical Cancer
• Uterine Cancer
• Ovarian Cancer

Intervention

Device: PAMS I

After general anesthesia, pressure sensor of PAMS I is placed into bladder, vagina and rectum. Then pressure change is monitored during performing pelvic autonomic nerve dissection.

Both PAMS I and IOM will be used for monitoring.

Study Arms

Experimental: PAMS I

During operation, autonomic nerve monitoring will be performed by PAMS I which is composed of two urodynamic systems.

Intervention: Device: PAMS I

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 30, 2016): 30
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Female, Age ≥ 18 years

• Patients with pelvic malignant tumor who need surgery.

  • Gynecologic cancer; cervical cancer, uterine cancer, ovarian cancer
  • Colorectal cancer
  • Pelvic sarcoma and metastatic pelvic malignant tumor
• Patients who signed an approved informed consent.

Exclusion Criteria:

• Female, Age < 18 years
• Patients with pelvic malignant tumor, but surgery is not indicated.
• Patients who refused to sign informed consent

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02952183
• Other Study ID Numbers: 2015-2092
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Hee Seung Kim, Seoul National University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Seoul National University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Hee Seung Kim, MD; Seoul National University Hospital

• PRS Account: Seoul National University Hospital
• Verification Date: October 2016