Status:
UNKNOWN
Safety and Aesthetic Outcomes of Breast Conserving Surgery With Peri-areolar Incision Approach
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-60 years
Phase:
PHASE3
Brief Summary
Cosmetic result after breast-conserving surgery (BCS) would impose great effect upon patient's quality of life. Although peri-areolar incision has been widely used in benign breast tumor excision, mas...
Detailed Description
The Trial aims to determine whether BCS with the peri-areolar approach: 1) is safe in terms of the rates of recurrence and metastasis; 2) can improve the post-operative aesthetic score and QOL score.
Eligibility Criteria
Inclusion
- patients desire for breast conserving surgery;
- 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
- patients not suitable for breast conserving surgery;
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01412788
Start Date
January 1 2007
Last Update
August 9 2011
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730