Clinical Trial

Comparison Between Prepectoral and Subpectoral Breast Reconstruction

Study acronym: RESPECT
Recruiting
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Record status
This record was last updated April 27, 2023 (before its estimated March 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT05833659
Lead Sponsor Beijing Friendship Hospital
Collaborators: Beijing Health Promotion Association
Conditions Stage II Breast Cancer, Stage I Breast Cancer
Enrollment 88 participants
Start Date 2022-03-01
Primary Completion 2025-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2023-04-27