Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer

Study Overview
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Brief Summary
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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

Official Title
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THE ROLE OF FLOSEAL IN THE PREVENTION OF LYMPHOCELE AND LYMPHATIC ASCITES AFTER LYMPH NODE DISSECTION FOR GYNECOLOGIC CANCER: A RANDOMIZED CONTROLLED TRIAL

Conditions
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Gynecologic Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Fallopian Tubal Cancer

Intervention / Treatment
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* Drug: FloSeal application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed primary cancer of the uterine cervix, uterine corpus, ovary, and fallopian tube FIGO stage Cervical cancer: FIOG stage IA2-IIA2 Uterine cancer: FIGO stage I-III Ovarian and fallopian tubal cancer: FIGO stage I-IIIB Patients who undergoing surgery including pelvic and/or para-aortic lymph node dissection Patients with adequate bone marrow, renal and hepatic function: 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 American Society of Anesthesiology Physical Status 0-1 Performance status of ECOG 0-2 Patient must be suitable candidates for surgery Patients who have signed an approved Informed Consent Exclusion Criteria: Patients with a history of pelvic or abdominal radiotherapy; Patients who are pregnant Patients with contraindications to surgery; Patients who are unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator); Patient's compliance and geographic proximity that do not allow adequate follow-up. Patients who undergo only lymph node sampling

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FloSeal group<br>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. | Drug: FloSeal application<br>* At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.<br>|
| No Intervention: No FloSeal group<br>All surgical procedures of control group is the same with study group except that Floseal is not applicated in control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of lymphocele an lymphatic ascites |  | within 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |