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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-08

Study Completion Date

2025-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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3D-reconstruction group

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.

Group Type EXPERIMENTAL

3D reconstruction technology

Intervention Type 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.

Normal group

Participants are not evaluated preoperatively using 3D reconstruction technology and flap separation is performed using electrosurgical knife intraoperatively.

Group Type ACTIVE_COMPARATOR

3D reconstruction technology

Intervention Type 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.

Interventions

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3D 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No