NCT06071234

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

An Exploration of 3D Reconstruction Tool for Preoperative Evaluation in Reducing Ischemic Complications of Flap and Nipple-Areolar Complex (NAC) After Nipple-sparing Mastectomy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2023-10-08
• Primary completion: 2025-04-30
• Completion: 2025-12-30
• First posted: 2023-10-06
• Last updated: 2025-01-23

Locations

1 site across 1 country: China