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The goal of this clinical study is to explore whether preoperative application of 3D reconstruction tool can reduce the occurrence of ischemic complications in the flap and nipple areola complex after surgery.
The 3D reconstruction tool was applied preoperatively to assess the blood supply and volume of participants' breasts and to recommend personalized prosthesis volume. Compared with electrosurgical knife separation,the flap was separated intraoperatively using a combination of cold knife and electrosurgical knife to observe whether there was a difference in the incidence of ischemic complications of participants' nipple areola complex and flap, and whether the use of the 3D tool in the preoperative assessment was effective in reducing the occurrence of postoperative ischemic complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D-reconstruction group | Experimental | The participant's breast blood supply was assessed preoperatively using 3D reconstruction technology, and the flap was separated intraoperatively using a combination of electrocautery and sharp dissection. |
|
| Normal group | Active Comparator | Participants are not evaluated preoperatively using 3D reconstruction technology and flap separation is performed using electrosurgical knife intraoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D reconstruction technology | Procedure | Preoperative application of 3D reconstruction technology to evaluate the breast blood supply of participants and observe whether the incidence of ischemic complications in the flap and nipple areola complex is reduced compared to surgery without preoperative evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic complications of flap and nipple areola complex | The incidence of ischemic complications in the skin flap and nipple areola complex after NSM surgery | 1 week and 2 week after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of ischemic complications in the flap and nipple areola complex | Severity of ischemic complications in the skin flap and nipple areola complex after NSM surgery | 1 week and 2 week after surgery |
| Duration of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | 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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|
Record the duration of the procedure from the beginning of the incision to the end of the closure of the skin.
| postoperative |
| Blood loss | Comparison of hemoglobin values in the preoperative blood test with the results of 2-h postoperative test | Preoperative and 2 hours postoperatively |
| Breast-Q Satisfaction | The outcome will be the score (continuous variable ranging from 0 to 100 for linear regression or ordinal categories, ranging from 1 to 4 for ordinallogistic regression, where 1 represents lowest satisfaction and 4 represents highest satisfaction), and the primary predictor of interest will be type of consultation provided. | Preoperative, 3 months and 1 year postoperatively |
| D017437 |
| Skin and Connective Tissue Diseases |