Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer
NCT ID: NCT01974193
Last Updated: 2015-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
40 participants
INTERVENTIONAL
2013-12-31
2016-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Study Groups
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Floseal
application of floseal to one side of pelvis after pelvic lymphadenectomy
Floseal
application of floseal on intervention arm
Control
counter-site of pelvis; no intervention after pelvic lymphadenectomy
No interventions assigned to this group
Interventions
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Floseal
application of floseal on intervention arm
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
80 Years
FEMALE
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Ewha Womans University Mokdong Hospital
OTHER
Responsible Party
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Yun Hwan KIM
Assistant Professor
Locations
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Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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BFL01
Identifier Type: -
Identifier Source: org_study_id
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