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

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: Baxter Healthcare Corporation

Criteria

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