Preoperative Evaluation of 3D Reconstruction Tool for Nipple-sparing Mastectomy

N/AActive Not RecruitingNCT06071234

Guangdong Provincial People's Hospital126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

126

Conditions

Breast Cancer

Interventions

3D reconstruction technologyPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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;

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Ischemic complications of flap and nipple areola complex

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

Secondary Outcomes

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

Time frame: 1 week and 2 week after surgery

Duration of surgery

Record the duration of the procedure from the beginning of the incision to the end of the closure of the skin.

Time frame: postoperative

Blood loss

Comparison of hemoglobin values in the preoperative blood test with the results of 2-h postoperative test

Time frame: 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.

Time frame: Preoperative, 3 months and 1 year postoperatively

Data from ClinicalTrials.gov

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