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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAMS I | Experimental | During operation, autonomic nerve monitoring will be performed by PAMS I which is composed of two urodynamic systems. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Quality of life. | Voiding/Defecation/Sexual function | Preoperative, 3 months after surgery |
| Time period for recovering normal voiding function | Check residual urine. Keep CIC until residual urine < 100cc |
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Inclusion Criteria:
Female, Age ≥ 18 years
Patients with pelvic malignant tumor who need surgery.
Patients who signed an approved informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hee Seung Kim, MD | Contact | 82-2-2072-4863 | bboddi0311@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hee Seung Kim, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D014594 | Uterine Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| postoperative (up to 6 month) |
| Urodynamic test | Preoperative, 3 months after surgery |
| Anorectal manometry | Preoperative, 3 months after surgery |
| D002577 |
| Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |