Safety and Aesthetic Outcomes of Breast Conserving Surgery With Peri-areolar Incision Approach
NCT ID: NCT01412788
Last Updated: 2011-08-09
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
100 participants
INTERVENTIONAL
2007-01-31
Brief Summary
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This trial was design to compare the Safety and aesthetic outcomes of breast conserving surgery between peri-areolar incision approach and traditional methods.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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peri-areolar incision
Peri-areolar incision was used to carry out lumpectomy
peri-areolar incision
peri-areolar incision was used to carry out lumpectomy in breast-conserving surgery.
traditional incision
traditional incision above tumor was used to carry out lumpectomy
traditional incision
Traditional incision above tumor was used to carry out breast-conserving surgery.
Interventions
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peri-areolar incision
peri-areolar incision was used to carry out lumpectomy in breast-conserving surgery.
traditional incision
Traditional incision above tumor was used to carry out breast-conserving surgery.
Eligibility Criteria
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Inclusion Criteria
* fulfills criteria for breast conserving surgery;
* the maximum diameter of the tumor should be less than the semi-perimeter of the areola and that the proximal margin of tumor should be at least 1 cm away from the areola;
* patients suitable to receive BCS with either the peri-areolar incision or the traditional incision were included;
Exclusion Criteria
* skin or sub-cutaneous tumor invasion as definite contra-indication of skin-sparing;
* male or bilateral breast cancers who might bring up bias in deciding aesthetic outcomes and expenditure;
* Patients who were supposed to benefit from a certain kind of incision were also excluded at the researcher's discretion.
18 Years
60 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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the department of breast surgery of PUMCH
Principal Investigators
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Sun Qiang, Master
Role: STUDY_CHAIR
PUMCH
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PUMCH- BCS
Identifier Type: -
Identifier Source: org_study_id
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