Randomized Controlled Trial of Safety and Aesthetic Outcomes of Breast-conserving Surgery With the Peri-areolar Incision Approach
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- event free survival
Study Overview
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, 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
traditional incision
traditional incision above tumor was used to carry out lumpectomy
Intervention: traditional incision (Procedure)
peri-areolar incision
Peri-areolar incision was used to carry out lumpectomy
Intervention: peri-areolar incision (Procedure)
Outcomes
Primary Outcomes
event free survival
Time Frame: 5 years
local recurrence, regional recurrence, distant metastasis, death
Secondary Outcomes
- cost(2 weeks)
- aesthetic outcomes(two weeks, half a year and one year)