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Trial Title:
Safety and Aesthetic Outcomes of Breast Conserving Surgery With Peri-areolar Incision Approach
NCT ID:
NCT01412788
Condition:
Breast Cancer
Conditions: Official terms:
Surgical Wound
Conditions: Keywords:
breast cancer
Breast Conserving Surgery
Peri-areolar Incision
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
peri-areolar incision
Description:
peri-areolar incision was used to carry out lumpectomy in breast-conserving surgery.
Arm group label:
peri-areolar incision
Intervention type:
Procedure
Intervention name:
traditional incision
Description:
Traditional incision above tumor was used to carry out breast-conserving surgery.
Arm group label:
traditional incision
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Sun Qiang, Master
Phone:
86-010-88068936
Email:
sunq@medmail.com.cn
Contact backup:
Last name:
Shen Songjie, Doctor
Phone:
86-010-88068936
Email:
pumcssj@163.com
Investigator:
Last name:
Sunq Qiang, Master
Email:
Principal Investigator
Start date:
January 2007
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01412788
