Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
NCT Number: NCT06071234
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–70 year
Female
Interventional
Not applicable
Guangzhou, Guangdong, 510080, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 week and 2 week after surgery
The incidence of ischemic complications in the skin flap and nipple areola complex after NSM surgery
Time frame: 1 week and 2 week after surgery
Severity of ischemic complications in the skin flap and nipple areola complex after NSM surgery
Time frame: postoperative
Record the duration of the procedure from the beginning of the incision to the end of the closure of the skin.
Time frame: Preoperative and 2 hours postoperatively
Comparison of hemoglobin values in the preoperative blood test with the results of 2-h postoperative test
Time frame: 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.
Guangdong Provincial People's Hospital
Other
An Exploration of 3D Reconstruction Tool for Preoperative Evaluation in Reducing Ischemic Complications of Flap and Nipple-Areolar Complex (NAC) After Nipple-sparing Mastectomy
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