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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Procedure: traditional incision; Procedure: peri-areolar incision

Study type: Interventional

Funder types: Other

Identifiers

NCT01412788

PUMCH- BCS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

peri-areolar incision

Experimental group

Description:

Peri-areolar incision was used to carry out lumpectomy

Treatment:

Procedure: peri-areolar incision

traditional incision

Active Comparator group

Description:

traditional incision above tumor was used to carry out lumpectomy

Treatment:

Procedure: traditional incision