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Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer

Primary Purpose

Gynecologic Cancer

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Floseal
Sponsored by
Ewha Womans University Mokdong Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gynecologic Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Gynecologic cancer patients who need laparotomic bilateral PLND

Exclusion Criteria:

  • Incomplete PLND which can influence the occurrence of lymphocele (surgeon's decision)

Sites / Locations

  • Ewha Womans University Mokdong HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Floseal

Control

Arm Description

application of floseal to one side of pelvis after pelvic lymphadenectomy

counter-site of pelvis; no intervention after pelvic lymphadenectomy

Outcomes

Primary Outcome Measures

Frequency of pelvic lymphocele
Frequency of ipsilateral pelvic lymphocele at post-operative 6th month.

Secondary Outcome Measures

Post-operative drainage
left and right post-operative drainage
lymphedema
lymphedema symptoms and sign at post-operative 3 and 6 month

Full Information

First Posted
October 28, 2013
Last Updated
February 10, 2015
Sponsor
Ewha Womans University Mokdong Hospital
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01974193
Brief Title
Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer
Official Title
Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University Mokdong Hospital
Collaborators
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pelvic lymph node dissection (PLND) is an important step in the surgical staging and treatment of gynecologic malignancies. Sometimes, complicated lymphoceles after PLND often delay adjuvant treatment including chemotherapy and radiation therapy, which potentially affects the success of cancer treatment. A number of surgical techniques have developed, but failed to reduce the incidence of pelvic lymphoceles after PLND. The investigators hypothesized that floseal can prevent lymphoceles in patients with gynecologic cancer who has undergone PLND. The investigators designed prospective randomized controlled study as a pilot study. The investigators will randomly apply floseal to one side of pelvis after bilateral PLND, and observe the occurence of pelvic lymphoceles after 6 months later.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Floseal
Arm Type
Experimental
Arm Description
application of floseal to one side of pelvis after pelvic lymphadenectomy
Arm Title
Control
Arm Type
No Intervention
Arm Description
counter-site of pelvis; no intervention after pelvic lymphadenectomy
Intervention Type
Drug
Intervention Name(s)
Floseal
Intervention Description
application of floseal on intervention arm
Primary Outcome Measure Information:
Title
Frequency of pelvic lymphocele
Description
Frequency of ipsilateral pelvic lymphocele at post-operative 6th month.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Post-operative drainage
Description
left and right post-operative drainage
Time Frame
post-operative 3 days
Title
lymphedema
Description
lymphedema symptoms and sign at post-operative 3 and 6 month
Time Frame
post-operative 3 and 6 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gynecologic cancer patients who need laparotomic bilateral PLND Exclusion Criteria: Incomplete PLND which can influence the occurrence of lymphocele (surgeon's decision)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Hwan Kim, Dr
Phone
+82-10-9096-7875
Email
medok74@gmail.com
Facility Information:
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer

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