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

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

To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection

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