Clinical trial NCT02952183: Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors
Official title: Exploratory Study for Evaluating the Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors (FUSION Trial V)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Uterine Cancer
Ovarian Cancer
Keywords: Autonomic nerve monitoring
Nerve-sparing surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluating efficacy of PAMS I by comparison with IOM
timeFrame: Intraoperative
Secondary outcomes:
measure: Evaluation of Quality of life.
timeFrame: Preoperative, 3 months after surgery
measure: Time period for recovering normal voiding function
timeFrame: postoperative (up to 6 month)
measure: Urodynamic test
timeFrame: Preoperative, 3 months after surgery
measure: Anorectal manometry
timeFrame: Preoperative, 3 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee Seung Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: