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Safety and Aesthetic Outcomes of Breast Conserving Surgery With Peri-areolar Incision Approach
Conditions
Breast Cancer
Conditions: Keywords
breast cancer, Breast Conserving Surgery, Peri-areolar Incision
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: peri-areolar incision
Type: Procedure
Name: traditional incision
Type: Procedure
Overall Status
Recruiting
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, mastopexy procedures and skin-sparing mastectomy with primary reconstruction, the actual safety and aesthetic outcome of the peri-areolar incision approach in BCS for cancer patients has not been established by randomized, controlled trials.
This trial was design to compare the Safety and aesthetic outcomes of breast conserving surgery between peri-areolar incision approach and traditional methods.
This trial was design to compare the Safety and aesthetic outcomes of breast conserving surgery between peri-areolar incision approach and traditional methods.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 60 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:
- 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 Criteria:
- 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.
- 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 Criteria:
- 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.
Location
Peking Union Medical College Hospital
Beijing, Beijing, China
Status: Recruiting
Contact: Sun Qiang, Master - 86-010-88068936 - sunq@medmail.com.cn
Start Date
January 2007
Sponsors
Peking Union Medical College Hospital
Source
Peking Union Medical College Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page