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To compare the incidence of lymphocele in Endometrial cancer patients with thrombin gel matrix used and not used during pelvic lymph node dissection.
Pelvic lymph node dissection is the most accurate staging tool to determine lymph node involvement in endometrial cancer. Lymphoceles developed after surgery can cause serious morbidity, additional costs and delays in chemotherapy or radiotherapy. In this study, conventional pelvic lymphadenectomy will be compared with thrombin gel matrix application after pelvic lymphadenectomy. Our goal is to prospectively assess the lymphostatic effect of thrombin gel matrix in endometrial cancer patients undergoing pelvic lymph node dissection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional pelvic lymphadenectomy | Active Comparator | Conventional pelvic lymphadenectomy |
|
| Thrombin gel matrix pelvic lymphadenectomy | Experimental | Thrombin gel matrix applicated after conventional pelvic lymphadenectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombi-Gel | Drug | Thrombin gel Matrix applied on pelvic lymphadenectomy areas after lympadenectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of pelvic lymphocele | Frequency pelvic lymphocele at post-operative 2th month | post-operative 2th month |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of radiographic lymphoceles | Volume of lymphocele detected with radiographic imagining at post-operative 2th month (the two largest dimensions measured in centimetres) | post-operative 2th month |
| duration of postoperative drainage catheter |
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Inclusion Criteria:
Exclusion Criteria:
Women
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| Name | Affiliation | Role |
|---|---|---|
| Åžener Gezer, M.D | Kocaeli University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli University | Kocaeli | 41380 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28382800 | Background | Kim YH, Shin HJ, Ju W, Kim SC. Prevention of lymphocele by using gelatin-thrombin matrix as a tissue sealant after pelvic lymphadenectomy in patients with gynecologic cancers: a prospective randomized controlled study. J Gynecol Oncol. 2017 May;28(3):e37. doi: 10.3802/jgo.2017.28.e37. Epub 2017 Feb 28. |
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| ID | Term |
|---|---|
| D008210 | Lymphocele |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Application of Thrombin gel matrix after Pelvic lymphadenectomy. And compare this application with Conventional Pelvic Lymphadenectomy.
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| Conventional Pelvic lymphadenectomy | Procedure | Conventional Pelvic lymphadenectomy |
|
duration of postoperative drainage catheter
| up to post-operative 1 week |
| Postoperative drain amount (ml: milliliters) | Postoperative drain amount (ml: milliliters) | with 1 weeks after surgery |
| D014594 |
| Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |