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

Asan Medical Center

Status: Completed

Conditions: Endometrial Cancer; Gynecologic Cancer; Fallopian Tubal Cancer; Ovarian Cancer; Cervical Cancer

Treatments: Drug: FloSeal application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01679483

FloSeal-LND

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups

FloSeal group

Experimental 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.

Treatment:

Drug: FloSeal application

No FloSeal group

No Intervention group

Description:

All surgical procedures of control group is the same with study group except that Floseal is not applicated in control group.