Brief Title
Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer
Official Title
THE ROLE OF FLOSEAL IN THE PREVENTION OF LYMPHOCELE AND LYMPHATIC ASCITES AFTER LYMPH NODE DISSECTION FOR GYNECOLOGIC CANCER: A RANDOMIZED CONTROLLED TRIAL
Brief Summary
To compare the incidence of lymphocele and lymphatic ascites between patient who use versus
who do not use FloSeal during lymph node dissection
Study Type
Interventional
Primary Outcome
Incidence of lymphocele an lymphatic ascites
Secondary Outcome
Time interval from surgery to removal of closed drain system
Condition
Gynecologic Cancer
Intervention
FloSeal application
Study Arms / Comparison Groups
FloSeal group
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
September 2012
Completion Date
November 2015
Primary Completion Date
November 2015
Eligibility 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
Gender
Female
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Joo-Hyun Nam, M.D., Ph.D., ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01679483
Organization ID
FloSeal-LND
Responsible Party
Principal Investigator
Study Sponsor
Asan Medical Center
Collaborators
Baxter Healthcare Corporation
Study Sponsor
Joo-Hyun Nam, M.D., Ph.D., Principal Investigator, Asan Medical Center
Verification Date
May 2017