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

NCT02952183 | Unknown DMC

• 1 other identifier: 2015-2092
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Development of pelvic autonomic nerve monitoring system (PAMS I) by using urodynamic system.
2. 2.Evaluation of autonomic nerve sparing by intraoperative monitoring with PAMS I
3. 3.Evaluating the efficacy of PAMS I by intraoperative neurophysiological monitoring (IOM)

Conditions

Cervical Cancer; Uterine Cancer; Ovarian Cancer

Keywords

Autonomic nerve monitoring; Nerve-sparing surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluation of Quality of life.

  Preoperative, 3 months after surgery

• Time period for recovering normal voiding function

  postoperative (up to 6 month)

• Urodynamic test

  Preoperative, 3 months after surgery

• Anorectal manometry

  Preoperative, 3 months after surgery

Study Arms (1)

PAMS I

EXPERIMENTAL

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

Device: PAMS I

Interventions

PAMS I 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.

PAMS I

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Hee Seung Kim, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Seung Kim, MD

CONTACT

82-2-2072-4863; bboddi0311@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: November 2, 2016
• Study Start: July 1, 2015
• Primary Completion: August 1, 2018
• Last Updated: November 2, 2016

Record last verified: 2016-10

Locations

KR (1)