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NOT YET RECRUITING
NCT07257003
NA

A Nationwide Multicenter, Single-arm, Retrospective Study of Delayed Endoscopic DTI-BR After Simple Mastectomy

Sponsor: Du Zhenggui

View on ClinicalTrials.gov

Summary

This study is a nationwide multicenter, single-arm, retrospective study. The study aims to conduct a detailed analysis of operation-related parameters, aesthetic outcomes (e.g., BREAST-Q scores and Harris scores), and safety (e.g., surgical complication rates) in delayed endoscopic direct-to-implant breast reconstruction via the axillary approach.

Official title: A Nationwide Multicenter, Single-arm, Retrospective Study on Delayed Endoscopic Direct-to-implant Breast Reconstruction Via Axillary Approach After Simple Mastectomy in Breast Cancer Patients

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-12-01

Completion Date

2026-12-31

Last Updated

2025-12-02

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomy

This technique allows for breast reconstruction in a single operation. Taking dual-plane breast reconstruction as an example, preoperative marking lines are drawn to indicate the contour and inframammary fold of the reconstructed breast. A 4-5 cm axillary incision is placed one finger-breadth below the axillary apex. After making the skin incision, the plane between the pectoralis major and minor muscles is identified and dissected, extending approximately 2 cm below the previous mastectomy horizontal scar. The inner and lower parts of the pectoralis major muscle were then separated. Proceed to the subcutaneous layer and continue to dissociate the flap until it reaches the pre-designed folds and the breast boundary. The use of the TiLOOP® Bra depends on the thickness of the patient's flap. Finally, the prosthesis is placed behind the pectoralis major muscle for breast reconstruction.

Locations (1)

West China hospital of Sichuan University

Chengdu, Sichuan, China