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

Not Applicable

• Conditions: Uterine Cancer; Ovarian Cancer; Cervical Cancer
• Interventions: Device: PAMS I

• Registration Number: NCT02952183
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2015-07
• Status Verified: 2016-10
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-30
• Last Update Submitted: 2016-10-30
• Study First Posted: 2016-11-02
• Last Update Posted: 2016-11-02
• Primary Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Evaluating efficacy of PAMS I by comparison with IOM	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of