Actively Recruiting
Prospective Study Comparing Minimally Invasive Endoscopic and Robotic Surgery with Traditional Open Surgery for Nipple-Sparing Mastectomy Combined with Immediate Prosthesis Breast Reconstruction
Led by Peking University People's Hospital · Updated on 2025-01-07
484
Participants Needed
1
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Breast cancer is the most common malignant tumor in women, and surgery is a key treatment for early-stage breast cancer. Many patients face physical and psychological challenges due to breast removal. Although breast-conserving surgery is increasing in China, over half of patients cannot retain their breasts because of their condition. For these patients, immediate breast reconstruction after nipple-sparing mastectomy (NSM) is important to improve appearance. This study compares minimally invasive endoscopic or robotic NSM with immediate prosthesis reconstruction to traditional open surgery, focusing on safety, complications, and patient outcomes in a large prospective cohort. Participants will undergo either endoscopic/robotic NSM combined with immediate prosthesis breast reconstruction or traditional open surgery at Peking University People's Hospital between January 1, 2025, and December 31, 2028. The study includes patients who will have the prosthesis wrapped partially or fully with non-biological patches during surgery. The study aims to evaluate perioperative complications, tumor safety, and patient-reported outcomes between these surgical methods. During the study, researchers will track the incidence of postoperative complications over 3 months. Patients will complete patient-reported outcome measures (PROMs) questionnaires to assess satisfaction and quality of life. The study collects clinical, pathological, and surgical data to compare safety and effectiveness. Participants' progress will be monitored throughout the perioperative period to provide comprehensive data on both surgical approaches.
CONDITIONS
Official Title
Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Underwent surgical treatment at Peking University People's Hospital with hospitalization records
- Breast cancer confirmed by preoperative core needle biopsy
- Clinical tumor stage 0 to IIIB
- Tumor size 5 cm or less, clinical node status cN0 or cN1, no distant metastasis (M0)
- No tumor invasion of the nipple areola complex, skin, or chest wall
- Intraoperative plan to use non-biological patches (e.g., TiLoop) to wrap the prosthesis partially or completely
- Signed agreement to participate in the study
- Able to complete Patient Reported Outcome Measures (PROMs) questionnaire
You will not qualify if you...
- Lack of clinical pathological data such as imaging or pathology reports
- Pregnancy or lactation
- Metastatic breast cancer or bilateral breast cancer
- Previous breast conserving surgery or chest radiation therapy
- Nipple areola complex invasion requiring removal
- Failure to undergo curative surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
Y
yuan peng, doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here