Clinical Trial Comparing Outcomes of Breast Conserving Operations With Classic v High-frequency Electrocoagulation
NCT ID: NCT01216254
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
PHASE4
150 participants
INTERVENTIONAL
2010-10-31
2013-10-31
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
TREATMENT
SINGLE
Study Groups
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Classic electrocoagulation
Arm of the study where the classic low-frequency electrocoagulation is used during the operation
classic v high-frequency electrocoagulation
During the BCT with SLND the investigators would use two types of electrocoagulation. The steps of the operation would remain the same in both arms, nevertheless the tool used would vary.
High Frequency electrocoagulation
Arm of the study where the tested high-frequency electrocoagulation is used during the operation
classic v high-frequency electrocoagulation
During the BCT with SLND the investigators would use two types of electrocoagulation. The steps of the operation would remain the same in both arms, nevertheless the tool used would vary.
Interventions
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classic v high-frequency electrocoagulation
During the BCT with SLND the investigators would use two types of electrocoagulation. The steps of the operation would remain the same in both arms, nevertheless the tool used would vary.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 18-100
* breast cancer
* stage IIA and II B (cT1a-3; cN0-1; cM0)
* no previous breast surgery
* no previous cancer
* obtained informed consent
Exclusion Criteria
* localised breast infection
* previous breast surgery for any cause
* previous cancer
* no voluntary consent
18 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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Jacek Zielinski, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Gdansk
Janusz Jaskiewicz, M.D., Ph.D.
Role: STUDY_DIRECTOR
Medical University of Gdansk
Locations
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Department of Surgical Oncology
Gdansk, Pomeranian Voivodeship, Poland
Countries
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Central Contacts
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Other Identifiers
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NKEBN/219/2010
Identifier Type: -
Identifier Source: org_study_id