An observational study in Stage II Breast Cancer and Stage I Breast Cancer, sponsored by Beijing Friendship Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by Beijing Friendship Hospital · Observational
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.
Sample size and statistical analysis This study is an ambispective cohort study. According to the previous retrospective research data of the center, the breast satisfaction score is the main research object. The standard deviation was 2.6, the non-inferiority margin was 0.15, the test level was α=0.05, β=0.2, and a one-sided test was performed. Eighty patients will be needed for two cohorts in a 1:1 ratio. Considering the 10% loss to follow-up rate, 44 patients will be required to be enrolled in each group.
12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 88 is below the median of 184 across 2,643 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.
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Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) and having willingness for breast reconstruction.
Exclusion Criteria:
The patients received prepectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy
Procedure: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
The patients received subpectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy
Procedure: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
Group A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction
breast satisfaction
measured by BREAST-Q score
Time frame: 12 months after operation
Physical well-being of chest
measured by BREAST-Q score
Time frame: 12 months after operation
Animation deformity
confirmed by the doctor's physical examination
Time frame: 12 months after operation
Adverse events
according to Clavien-Dindo system
Time frame: within 30 days after surgery
Local recurrence and distant metastasis of breast cancer
physical examination or imaging examination with histologically confirmed
Time frame: 12 months after operation
Plan to share: Undecided
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Beijing Friendship Hospital