Effect of Early vs Late Drainage Removal in Women After Radical Mastectomy With Axillary Clearance
NCT ID: NCT01221064
Last Updated: 2012-01-31
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
NA
100 participants
INTERVENTIONAL
2010-10-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Early drainage removal
Patients randomised to early drainage removal arm will have the drain removed in postoperative day 1. Lymph will be punctured on a regular basis
Early drainage removal
Drainage will be removed in postoperative day 1
Late drainage removal
Patients randomised to late drainage removal arm will have the drains kept until total daily drainage is 30ml and then removed
Late drainage removal
Drains will be kept until daily drainage is 30ml and then removed
Interventions
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Early drainage removal
Drainage will be removed in postoperative day 1
Late drainage removal
Drains will be kept until daily drainage is 30ml and then removed
Eligibility Criteria
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Inclusion Criteria
* Obtaining informed consent
* Total amount of lymph in postoperative day 1 \<150ml
Exclusion Criteria
* History of benign breast neoplasm or malignant disease of any origin
* Any breast surgery in the past
* Weight \<50kg
18 Years
75 Years
FEMALE
No
Sponsors
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Medical University of Gdansk
OTHER
Responsible Party
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Jacek Zielinski
Assistant Profesor
Principal Investigators
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Janusz Jaśkiewicz, MD, PhD
Role: STUDY_DIRECTOR
Medical University of Gdansk
Jacek Zielinski, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Gdansk
Locations
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Medical University of Gdansk, Department of Surgical Oncology
Gdansk, Pomeranian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Jacek Zielinsk, MD, PhD
Role: primary
Pawel Kabata, MD
Role: backup
Other Identifiers
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MUGSO-001
Identifier Type: -
Identifier Source: org_study_id