Preoperative Evaluation of 3D Printing Technology for Nipple-sparing Mastectomy
Study Details
Study Description
Brief Summary
The goal of this clinical study is to explore whether preoperative application of 3D printing technology to evaluate breast blood supply can improve the occurrence of ischemic complications in the flap and nipple areola complex after surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Preoperatively, 3D printing technology was applied to assess the blood supply of the breast, and intraoperatively, the flap was separated using a cold knife combined with an electrosurgical knife, and comparisons were made between the flap and the conventional electrosurgical knife to observe whether there was a difference in the incidence of ischemic complications in the nipple areola complex and the flap and whether the use of 3D printing technology in preoperative assessment was able to effectively reduce the occurrence of ischemic complications in the postoperative period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 3D-printed group The patient's breast blood supply was assessed preoperatively using 3D printing technology, and the flap was separated intraoperatively using a combination of cold knife and electrosurgical knife. |
Procedure: 3D printed technology
Preoperative application of 3D printing technology to evaluate the breast blood supply of patients and observe whether the incidence of ischemic complications in the flap and nipple areola complex is reduced compared to conventional non preoperative evaluation.
|
| Active Comparator: Normal group Patients are not evaluated preoperatively using 3D printing technology and flap separation is performed using electrosurgical knife intraoperatively. |
Procedure: 3D printed technology
Preoperative application of 3D printing technology to evaluate the breast blood supply of patients and observe whether the incidence of ischemic complications in the flap and nipple areola complex is reduced compared to conventional non preoperative evaluation.
|
Outcome Measures
Primary Outcome Measures
- Ischemic complications of flap and nipple areola complex [1 week and 2 week after surgery]
The incidence of ischemic complications in the skin flap and nipple areola complex after NSM surgery
Secondary Outcome Measures
- Severity of ischemic complications in the flap and nipple areola complex [1 week and 2 week after surgery]
Severity of ischemic complications in the skin flap and nipple areola complex after NSM surgery
- Duration of surgery [postoperative]
Record the duration of the procedure from the beginning of the incision to the end of the closure of the skin.
- Blood loss [Preoperative and 2 hours postoperatively]
Comparison of hemoglobin values in the preoperative blood test with the results of 2-h postoperative test
- Breast-Q Satisfaction [Preoperative, 3 months and 1 year postoperatively]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pathologically confirmed diagnosis of breast cancer
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Age: 18 to 70 years old
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No infiltration of the nipple-areola complex and negative histopathology of the nipple basal margins;
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Patients who meet the indications for breast conserving surgery require total mastectomy and reconstruction;
Exclusion Criteria:
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Inability to tolerate surgery or subjective desire not to undergo nipple-sparing mastectomy;
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Patients with clinical or imaging evidence of preoperative involvement of the nipple/areolar region, including Paget's disease, nipple spillage, inflammatory breast cancer, and/or imaging findings suggesting malignant involvement of the nipple or subareolar tissues, according to the 2023 NCCN guideline recommendations, where retaining the NAC fails to yield negative margins;
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Guangdong Provincial People's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3D-PRT