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

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

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)

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer; Ovarian Cancer; Uterine Cancer
• Intervention / Treatment: Device: PAMS I

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
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hee Seung Kim, MD; Phone Number: 82-2-2072-4863; Email: bboddi0311@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Hee Seung Kim, MD; Phone Number: 82-2-2072-4863; Email: bboddi0311@gmail.com
    • Principal Investigator: Hee Seung Kim, MD
    • Contact: Seungmee Lee, MD; Phone Number: 82-2-2072-2821; Email: yumenoarika@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAMS I; During operation, autonomic nerve monitoring will be performed by PAMS I which is composed of two urodynamic systems.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating efficacy of PAMS I by comparison with IOM	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	Intraoperative

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 30, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: October 30, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Autonomic nerve monitoring; Nerve-sparing surgery
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Uterine Neoplasms
• Other Study ID Numbers: 2015-2092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED