Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer
Conditions
Gynecologic Cancer - Cervical Cancer - Endometrial Cancer - Ovarian Cancer - Fallopian Tubal Cancer
Conditions: official terms
Lymphocele - Uterine Cervical Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Intervention
Name: FloSeal application
Type: Drug
Overall Status
Recruiting
Summary
To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Female
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
Location
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Joo-Hyun Nam, M.D., Ph.D. - 82-2-3010-3633 - jhnam@amc.seoul.kr
Start Date
September 2012
Sponsors
Asan Medical Center
Source
Asan Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page