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

Not Applicable

Completed

• Conditions: Ovarian Cancer; Fallopian Tubal Cancer; Gynecologic Cancer; Endometrial Cancer; Cervical Cancer
• Interventions: Drug: FloSeal application

• Registration Number: NCT01679483
• Lead Sponsor: Asan Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2012-09-03
• Study First Posted: 2012-09-06
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-27
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FloSeal group	FloSeal application	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.

Primary Outcome Measures

Name	Time	Method
Incidence of lymphocele an lymphatic ascites	within 1 year after surgery

Secondary Outcome Measures

Name	Time	Method
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
Postoperative bleeding incidence	within 2 weeks after surgery
Postoperative complication incidence	within 1 month after surgery
Quality of life	within 1 year after surgery
2-year disease free survival and overall survival	2 years after surgery

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of