Gynecologic Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Fallopian Tubal Cancer
Conditions
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
Interventions
At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.
Sponsors
Baxter Healthcare Corporation
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of lymphocele an lymphatic ascites | within 1 year after surgery |
Secondary
| Measure | 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 |
| 2-year disease free survival and overall survival | 2 years after surgery |
| Postoperative complication incidence | within 1 month after surgery |
| Quality of life | within 1 year after surgery |
| Postoperative bleeding incidence | within 2 weeks after surgery |
Countries
South Korea
Outcome results
None listed