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In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.
In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required to ensure the efficiency of cure. Also, less scars and breast preservation has becoming more and more important for patients' acceptance to the treatment. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic breast-conserving surgery | Experimental | Subjects who is going to accept laparoscopic breast-conserving surgery. |
|
| Traditional open breast-conserving surgery | Active Comparator | Subjects who is going to accept traditional open breast-conserving surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic breast-conserving surgery | Procedure | Use laparoscopic surgery to treat breast cancer patients who want and have the opportunity to preserve their breast |
|
| Measure | Description | Time Frame |
|---|---|---|
| breast appearance satisfaction | Whether laparoscopic breast-conserving and traditional open breast-conserving had significant differences postoperative cosmetic outcomes. One of the evaluation indicators is breast appearance satisfaction. Our study chooses BREAST-Q questionnaire to evaluate patients' breast appearance satisfaction. | 2 years |
| breast aesthetic scores | Whether laparoscopic breast-conserving and traditional open breast-conserving had significant differences postoperative cosmetic outcomes. Another of the evaluation indicators is breast aesthetic scores. We will invite two Plastic surgeons who did not participate in the study to judge patients' photographs, which is taken 18 months after the surgery, according to the Harris evaluation criteria. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | The study focus on intraoperative/postoperative complications between endoscopic breast-conserving and traditional open breast-conserving, including bleeding, hematoma, seroma, poor wound healing, nipple/areola necrosis, incision infection and incision dehiscence. | 1 year |
| Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaochen - Wang, Doctorate | Contact | +86 13958161286 | wangxiaochen@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaochen - Wang, Doctorate | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiaochen Wang | Hangzhou | Zhejiang | 31000 | China |
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| Traditional open breast-conserving surgery | Procedure | Treat breast cancer patients who want and have the opportunity to preserve their breast with traditional open breast-conserving surgery. |
|
Whether laparoscopic breast-conserving and traditional open breast-conserving have difference in quality of life. The study measures the quality of life with the EORTC QLQ BR23 questionnaire launched by European Organization for Research and Treatment of Cancer. |
| 1 year |
| local recurrence rate | Whether laparoscopic breast-conserving and traditional open breast-conserving have difference in local recurrence rate. If local recurrence appears, record the time and location of recurrence. | 2 years |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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