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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| peri-areolar incision | Experimental | Peri-areolar incision was used to carry out lumpectomy |
|
| traditional incision | Active Comparator | traditional incision above tumor was used to carry out lumpectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peri-areolar incision | Procedure | peri-areolar incision was used to carry out lumpectomy in breast-conserving surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| event free survival | local recurrence, regional recurrence, distant metastasis, death | 5 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sun Qiang, Master | Contact | 86-010-88068936 | sunq@medmail.com.cn | |
| Shen Songjie, Doctor | Contact | 86-010-88068936 | pumcssj@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Sun Qiang, Master | PUMCH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| traditional incision | Procedure | Traditional incision above tumor was used to carry out breast-conserving surgery. |
|
| 2 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |