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

Primary Purpose

Gynecologic Cancer, Cervical Cancer, Endometrial Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
FloSeal application
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynecologic Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FloSeal group

No FloSeal group

Arm 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.

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

Outcomes

Primary Outcome Measures

Incidence of lymphocele an lymphatic ascites

Secondary Outcome Measures

Time interval from surgery to removal of closed drain system
Postoperative drain amount
Postoperative hospital stay
Postoperative bleeding incidence
Postoperative complication incidence
Quality of life
2-year disease free survival and overall survival

Full Information

First Posted
September 3, 2012
Last Updated
May 27, 2017
Sponsor
Asan Medical Center
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01679483
Brief Title
Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer
Official Title
THE ROLE OF FLOSEAL IN THE PREVENTION OF LYMPHOCELE AND LYMPHATIC ASCITES AFTER LYMPH NODE DISSECTION FOR GYNECOLOGIC CANCER: A RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Fallopian Tubal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FloSeal group
Arm Type
Experimental
Arm 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.
Arm Title
No FloSeal group
Arm Type
No Intervention
Arm Description
All surgical procedures of control group is the same with study group except that Floseal is not applicated in control group.
Intervention Type
Drug
Intervention Name(s)
FloSeal application
Intervention Description
At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.
Primary Outcome Measure Information:
Title
Incidence of lymphocele an lymphatic ascites
Time Frame
within 1 year after surgery
Secondary Outcome Measure Information:
Title
Time interval from surgery to removal of closed drain system
Time Frame
with 2 weeks after surgery
Title
Postoperative drain amount
Time Frame
with 2 weeks after surgery
Title
Postoperative hospital stay
Time Frame
within 2 weeks after surgery
Title
Postoperative bleeding incidence
Time Frame
within 2 weeks after surgery
Title
Postoperative complication incidence
Time Frame
within 1 month after surgery
Title
Quality of life
Time Frame
within 1 year after surgery
Title
2-year disease free survival and overall survival
Time Frame
2 years after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Hyun Nam, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

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

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