Comparison Between Prepectoral and Subpectoral Breast Reconstruction
NCT05833659 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 88
Last updated 2023-04-27
Summary
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
- Stage II Breast Cancer
- Stage I Breast Cancer
Interventions
- 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
Sponsors & Collaborators
-
Beijing Health Promotion Association
collaborator UNKNOWN -
Beijing Friendship Hospital
lead OTHER
Principal Investigators
-
guoxuan gao, MD · Department of General Surgery, Beijing Friendship Hospital, Capital Medical University
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-01
- Primary Completion
- 2025-03-31
- Completion
- 2027-03-31
Countries
- China
Study Locations
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