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

Phase 3

• Conditions: Breast Cancer
• Interventions: Procedure: traditional incision; Procedure: peri-areolar incision

• Registration Number: NCT01412788
• Lead Sponsor: Peking Union Medical College Hospital

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 Timeline

• Study Start: 2007-01
• Status Verified: 2011-08
• Study First Submitted: 2011-08-07
• Study First Submitted QC: 2011-08-08
• Last Update Submitted: 2011-08-08
• Study First Posted: 2011-08-09
• Last Update Posted: 2011-08-09
• Primary Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditional incision	traditional incision	traditional incision above tumor was used to carry out lumpectomy
peri-areolar incision	peri-areolar incision	Peri-areolar incision was used to carry out lumpectomy

Primary Outcome Measures

Name	Time	Method
event free survival	5 years	local recurrence, regional recurrence, distant metastasis, death

Secondary Outcome Measures

Name	Time	Method
cost	2 weeks	operation time for the surgery, hospital stay days, costs
aesthetic outcomes	two weeks, half a year and one year	aesthetic score and QOL score

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China