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

NCT ID: NCT02952183

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

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

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

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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.

Conditions

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Cervical Cancer Uterine Cancer Ovarian Cancer

Keywords

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Autonomic nerve monitoring Nerve-sparing surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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PAMS I

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

Group Type EXPERIMENTAL

PAMS I

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee Seung Kim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee Seung Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hee Seung Kim, MD

Role: CONTACT

Phone: 82-2-2072-4863

Email: [email protected]

Facility Contacts

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Seungmee Lee, MD

Role: primary

Hee Seung Kim, MD

Role: backup

Other Identifiers

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2015-2092

Identifier Type: -

Identifier Source: org_study_id