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

Study Overview
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Brief Summary
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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 Development of pelvic autonomic nerve monitoring system (PAMS I) by using urodynamic system. Evaluation of autonomic nerve sparing by intraoperative monitoring with PAMS I Evaluating the efficacy of PAMS I by intraoperative neurophysiological monitoring (IOM)

Detailed Description
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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.

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

Conditions
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Cervical Cancer, Uterine Cancer, Ovarian Cancer

Intervention / Treatment
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* Device: PAMS I


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAMS I<br>During operation, autonomic nerve monitoring will be performed by PAMS I which is composed of two urodynamic systems. | Device: PAMS I<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autonomic nerve monitoring, Nerve-sparing surgery