Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.
NCT ID: NCT02001857
Last Updated: 2017-08-25
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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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2013-09-30
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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TachoSil
TachoSil
1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.
at the end of surgery
No TachoSil
No TachoSil
No interventions assigned to this group
Interventions
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1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.
at the end of surgery
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of prostate cancer or bladder cancer on pathology
* Undergoing transperitoneal pelvic lymph node dissection.
Exclusion Criteria
* Any type of clotting disorder.
18 Years
99 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Nicolaas Lumen, MD, PhD, FEBU
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Ghent University Hospital
Ghent, , Belgium
Countries
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Other Identifiers
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2013-000782-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EC/2013/472
Identifier Type: -
Identifier Source: org_study_id
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