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

May 27, 2017 updated by: Joo-Hyun Nam, Asan Medical Center

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: within 1 year after surgery
within 1 year after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Time interval from surgery to removal of closed drain system
Time Frame: with 2 weeks after surgery
with 2 weeks after surgery
Postoperative drain amount
Time Frame: with 2 weeks after surgery
with 2 weeks after surgery
Postoperative hospital stay
Time Frame: within 2 weeks after surgery
within 2 weeks after surgery
Postoperative bleeding incidence
Time Frame: within 2 weeks after surgery
within 2 weeks after surgery
Postoperative complication incidence
Time Frame: within 1 month after surgery
within 1 month after surgery
Quality of life
Time Frame: within 1 year after surgery
within 1 year after surgery
2-year disease free survival and overall survival
Time Frame: 2 years after surgery
2 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Baxter Healthcare Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • FloSeal-LND

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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