Safety and Aesthetic Outcomes of Breast Conserving Surgery With Peri-areolar Incision Approach

Peking Union Medical College Hospital100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

event free survival

local recurrence, regional recurrence, distant metastasis, death

Time frame: 5 years

Secondary Outcomes

aesthetic outcomes

aesthetic score and QOL score

Time frame: two weeks, half a year and one year

cost

operation time for the surgery, hospital stay days, costs

Time frame: 2 weeks