To Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer (NJMU-Reconstruction Cohort)
NCT06817954 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800
Last updated 2026-05-01
Summary
The new technology of endoscopic-assisted system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of endoscopic-assisted mastectomy and immediate breast reconstruction in China in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. This prospective, single-center, double-arm clinical study was conducted to use the endoscopic-assisted system and evaluate the effectiveness and safety of the mastectomy combined with immediate breast reconstruction in breast cancer.
Conditions
Interventions
- PROCEDURE
-
endoscopic-assisted mastectomy and immediate breast reconstruction
endoscopic-assisted mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer
- PROCEDURE
-
mastectomy and immediate breast reconstruction
conventional mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer
Sponsors & Collaborators
-
The First Affiliated Hospital with Nanjing Medical University
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-01
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
Countries
- China
Study Locations
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