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

Seoul National University

Status: Unknown

Conditions: Uterine Cancer; Ovarian Cancer; Cervical Cancer

Treatments: Device: PAMS I

Study type: Interventional

Funder types: Other

Identifiers

NCT02952183

2015-2092

Details and patient eligibility

About

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)

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

PAMS I

Experimental group

Description:

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

Treatment:

Device: PAMS I