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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of Safety and Aesthetic Outcomes of Breast-conserving Surgery With the Peri-areolar Incision Approach

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: peri-areolar incision
* Procedure: traditional incision


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: peri-areolar incision<br>Peri-areolar incision was used to carry out lumpectomy | Procedure: peri-areolar incision<br>* peri-areolar incision was used to carry out lumpectomy in breast-conserving surgery.<br>|
| Active Comparator: traditional incision<br>traditional incision above tumor was used to carry out lumpectomy | Procedure: traditional incision<br>* Traditional incision above tumor was used to carry out breast-conserving surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| event free survival | local recurrence, regional recurrence, distant metastasis, death | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aesthetic outcomes | aesthetic score and QOL score | two weeks, half a year and one year | 
| cost | operation time for the surgery, hospital stay days, costs | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, Breast Conserving Surgery, Peri-areolar Incision