Cervical Cancer, Ovarian Cancer, Uterine Cancer
Conditions
Keywords
Autonomic nerve monitoring, Nerve-sparing surgery
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.
Interventions
DEVICEPAMS 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.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating efficacy of PAMS I by comparison with IOM | Intraoperative | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Quality of life. | Preoperative, 3 months after surgery | Voiding/Defecation/Sexual function |
| Time period for recovering normal voiding function | postoperative (up to 6 month) | Check residual urine. Keep CIC until residual urine \< 100cc |
| Urodynamic test | Preoperative, 3 months after surgery | — |
| Anorectal manometry | Preoperative, 3 months after surgery | — |
Countries
South Korea
Contacts
Primary ContactHee Seung Kim, MD
Outcome results
None listed