Breast Cancer
Conditions
Keywords
breast cancer, Breast Conserving Surgery, Peri-areolar Incision
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.
Interventions
PROCEDUREperi-areolar incision
peri-areolar incision was used to carry out lumpectomy in breast-conserving surgery.
PROCEDUREtraditional incision
Traditional incision above tumor was used to carry out breast-conserving surgery.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| event free survival | 5 years | local recurrence, regional recurrence, distant metastasis, death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| aesthetic outcomes | two weeks, half a year and one year | aesthetic score and QOL score |
| cost | 2 weeks | operation time for the surgery, hospital stay days, costs |
Countries
China
Contacts
Primary ContactSun Qiang, Master
Backup ContactShen Songjie, Doctor
Outcome results
None listed