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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FloSeal group | Experimental | This group will undergo appropriate cancer surgery for each patient with pelvic lymph node dissection +/- para-aortic lymph node dissection. At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area. |
|
| No FloSeal group | No Intervention | All surgical procedures of control group is the same with study group except that Floseal is not applicated in control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FloSeal application | Drug | At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of lymphocele an lymphatic ascites | within 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time interval from surgery to removal of closed drain system | with 2 weeks after surgery | |
| Postoperative drain amount | with 2 weeks after surgery | |
| Postoperative hospital stay |
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Inclusion Criteria:
WBC > 3,000 cells/mcl Platelets >100,000/mcl Creatinine <2.0 mg/dL Bilirubin <1.5 x normal and SGOT or SGPT <3 x normal
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joo-Hyun Nam, M.D., Ph.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center | Seoul | 138-736 | South Korea |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| within 2 weeks after surgery |
| Postoperative bleeding incidence | within 2 weeks after surgery |
| Postoperative complication incidence | within 1 month after surgery |
| Quality of life | within 1 year after surgery |
| 2-year disease free survival and overall survival | 2 years after surgery |
| D009369 |
| Neoplasms |
| 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 |