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Breast cancer is the most common malignant tumor in women. Surgical treatment is the most important treatment for early breast cancer. Breast cancer resection is considered to be a destructive operation. Patients need to accept the double blow of physical and psychological loss of breast shape. Although with the change of the concept of early diagnosis and treatment of breast cancer, the breast conserving rate of breast cancer is gradually increasing in China, more than half of the patients are still unable to retain breast due to their condition. For these patients, breast reconstruction surgery is an important means to improve the postoperative breast shape. With the improvement of surgical technology, endoscopic/robotic NSM combined with immediate prosthesis breast reconstruction has been gradually developed. According to previous literature reports, it has good tumor safety and aesthetics, but it is still lack of large-scale prospective results.
This project plans to adopt a prospective cohort design, based on the large sample breast disease cohort database established by the breast center of Peking University People's Hospital, and prospectively include patients who receive NSM combined with immediate prosthesis reconstruction under endoscopy/robot and conventional surgery from January 1, 2025 to December 31, 2028. The perioperative complications, tumor safety and patient reported outcomes of the two methods were compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endoscopic and robotic surgery | nipple-sparing mastectomy under endoscopic/robotic surgery combined with immediate prosthesis reconstruction | ||
| conventional surgery | conventional nipple-sparing mastectomy combined with immediate prosthesis reconstruction |
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| Measure | Description | Time Frame |
|---|---|---|
| incidence of postoperative complications | Delayed wound healing, nipple and areola ischemia/necrosis, skin ischemia/necrosis, serum swelling, wound dehiscence/prosthesis exposure, infection, and prosthesis removal occurred within 3 months after surgery. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported Outcome Measures | BREAST-Q scores, higher scores mean a better outcome | 1 year |
| local-regional recurrence | From research enrollment to ipsilateral breast skin, subcutaneous, chest wall, axillary, internal mammary, and supraclavicular lymph node recurrence; |
| Measure | Description | Time Frame |
|---|---|---|
| tumour saftey | Pathology of residual cavity lavage fluid; Pathology of peripheral edge tissue in breast specimens. If we can see tumour cell in the lavage fluid or breast tissue on the peripheral edge means not safety. | 1 week |
Inclusion Criteria:
5) Intraoperative plan to use non biological patches (such as TiLoop) to partially or completely wrap the prosthesis 6) Signed agreement to participate in this study; 7) Can cooperate to complete the Patient Reported Outcome Measures (PROMs) questionnaire.
Exclusion Criteria:
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Prospective inclusion of patients who underwent minimally invasive surgery (endoscopic and robotic surgey) and conventional surgery at Peking University People's Hospital from January 1, 2025.01 to December 31, 2028.12 to preserve the NSM with immediate prosthesis breast reconstruction
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yuan peng, doctor | Contact | 86+13671287670 | 13671287670@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| 5 years |
| Distant metastasis free survival | the time from enrollment in the study to the occurrence of distant recurrence and metastasis; | 5 years |
| Disease free survival | the time from study enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause. | 5 years |