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

THE ROLE OF FLOSEAL IN THE PREVENTION OF LYMPHOCELE AND LYMPHATIC ASCITES AFTER LYMPH NODE DISSECTION FOR GYNECOLOGIC CANCER: A RANDOMIZED CONTROLLED TRIAL

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

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Gynecologic Cancer; Ovarian Cancer; Endometrial Cancer; Fallopian Tubal Cancer
• Intervention / Treatment: Drug: FloSeal application

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FloSeal group; 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.	Drug: FloSeal application; At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.
No Intervention: No FloSeal group; All surgical procedures of control group is the same with study group except that Floseal is not applicated in control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of lymphocele an lymphatic ascites	within 1 year after surgery

Secondary Outcome Measures

Outcome 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
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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: September 3, 2012
• First Submitted That Met QC Criteria: September 3, 2012
• First Posted (Estimate): September 6, 2012

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 27, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Lymphatic Diseases; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Cysts; Endometrial Neoplasms; Lymphocele
• Other Study ID Numbers: FloSeal-LND