Breast Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURE3D reconstruction technology
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.
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed diagnosis of breast cancer * Age: 18 to 70 years old * No infiltration of the nipple-areola complex and negative histopathology of the nipple basal margins; * Participants who meet the indications for breast conserving surgery require total mastectomy and reconstruction;
Exclusion criteria
* Inability to tolerate surgery or subjective desire not to undergo nipple-sparing mastectomy; * Participants 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed