Actively Recruiting
Comparison Between Prepectoral and Subpectoral Breast Reconstruction
Led by Beijing Friendship Hospital · Updated on 2023-04-27
88
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
B
Beijing Friendship Hospital
Lead Sponsor
B
Beijing Health Promotion Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthesis reconstruction. The study's primary objective is to compare single-port endoscopic NSM combined with pre-pectoral breast reconstruction to the subpectoral breast reconstruction group regarding breast satisfaction. This study is an ambispective cohort study. The study will be conducted at Beijing Friendship Hospital, affiliated with Capital Medical University. Patients will be enrolled retrospectively from January 2014 to March 2022 by reviewing the medical records and recruited prospectively from March 2022 to March 2025. The two cohorts are the pre-pectoral breast reconstruction cohort and the subpectoral breast reconstruction cohort, both following single-port insufflation endoscopic nipple-sparing mastectomy. The primary outcome of this study is postoperative breast satisfaction, which the BREAST-Q score will measure. The different variables will be compared using the Χ2 test for categorical variables and the Mann-Whitney test for continuous variables.
CONDITIONS
Official Title
Comparison Between Prepectoral and Subpectoral Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or II) by core needle biopsy
- Breast-conserving surgery is not possible or patient requests total mastectomy
- Willingness for breast reconstruction
- Age between 18 to 70 years
- Maximum cancer lesion diameter of 3 cm or less
- No tumor invasion of skin, subcutaneous tissue, or chest wall confirmed by exam and MRI
- Distance between lesion and nipple at least 2 cm, with no nipple-areola complex invasion confirmed
- Eastern Cooperative Oncology Group (ECOG) Performance Status Scale of 0 to 2
You will not qualify if you...
- Serious medical diseases such as unstable angina pectoris, myocardial infarction, or cerebrovascular accident within 6 months
- History of malignant tumors within 5 years
- Under immunosuppressive therapy for organ transplantation
- Continuous systemic steroid hormone therapy
- Pregnant or lactating women
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital, Capital medical University
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
G
guoxuan gao, MD
CONTACT
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
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