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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
peri-areolar incision
traditional incision
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, Breast Conserving Surgery, Peri-areolar Incision

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

peri-areolar incision

traditional incision

Arm Description

Peri-areolar incision was used to carry out lumpectomy

traditional incision above tumor was used to carry out lumpectomy

Outcomes

Primary Outcome Measures

event free survival
local recurrence, regional recurrence, distant metastasis, death

Secondary Outcome Measures

aesthetic outcomes
aesthetic score and QOL score
cost
operation time for the surgery, hospital stay days, costs

Full Information

First Posted
August 7, 2011
Last Updated
August 8, 2011
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01412788
Brief Title
Safety and Aesthetic Outcomes of Breast Conserving Surgery With Peri-areolar Incision Approach
Official Title
Randomized Controlled Trial of Safety and Aesthetic Outcomes of Breast-conserving Surgery With the Peri-areolar Incision Approach
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, Breast Conserving Surgery, Peri-areolar Incision

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
peri-areolar incision
Arm Type
Experimental
Arm Description
Peri-areolar incision was used to carry out lumpectomy
Arm Title
traditional incision
Arm Type
Active Comparator
Arm Description
traditional incision above tumor was used to carry out lumpectomy
Intervention Type
Procedure
Intervention Name(s)
peri-areolar incision
Intervention Description
peri-areolar incision was used to carry out lumpectomy in breast-conserving surgery.
Intervention Type
Procedure
Intervention Name(s)
traditional incision
Intervention Description
Traditional incision above tumor was used to carry out breast-conserving surgery.
Primary Outcome Measure Information:
Title
event free survival
Description
local recurrence, regional recurrence, distant metastasis, death
Time Frame
5 years
Secondary Outcome Measure Information:
Title
aesthetic outcomes
Description
aesthetic score and QOL score
Time Frame
two weeks, half a year and one year
Title
cost
Description
operation time for the surgery, hospital stay days, costs
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sun Qiang, Master
Phone
86-010-88068936
Email
sunq@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shen Songjie, Doctor
Phone
86-010-88068936
Email
pumcssj@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Qiang, Master
Organizational Affiliation
PUMCH
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Qiang, Master
Phone
86-010-88068936
Email
sunq@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Shen Songjie, Doctor
Phone
86-010-88068936
Email
pumcssj@163.com
First Name & Middle Initial & Last Name & Degree
Sunq Qiang, Master

12. IPD Sharing Statement

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

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