Clinical Trial

Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction

Not Yet Recruiting
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Summary
This clinical trial aims to determine whether conventional surgery or endoscopic surgery results in better recovery of breast skin sensation in women with early-stage breast cancer undergoing nipple-sparing mastectomy with prepectoral implant reconstruction. Furthermore, the study will compare the safety, aesthetic outcomes, and quality of life associated with the two surgical approaches. The study seeks to address the following primary research questions: Does conventional surgery lead to superior recovery of breast skin sensation at 6 months postoperatively compared with endoscopic surgery? What are the differences between the two surgical approaches in terms of complication rates, aesthetic outcomes, and patient-reported quality of life? Researchers will compare conventional nipple-sparing mastectomy with endoscopic nipple-sparing mastectomy to determine which procedure better preserves postoperative breast sensation. Participants will: Be randomly assigned to undergo either conventional or endoscopic surgery. Have breast skin sensation measured preoperatively and at multiple postoperative follow-up visits using a standardized assessment tool. Complete validated questionnaires regarding breast satisfaction and quality of life preoperatively and during multiple follow-up visits. Attend scheduled follow-up visits to monitor for complications and to evaluate the long-term appearance and health of the reconstructed breast.
Trial Details
NCT Number NCT07372339
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions Breast Cancer
Enrollment 170 participants
Start Date 2026-03
Primary Completion 2028-03 (estimated)
Study Completion 2036-03 (estimated)
Updated on ClinicalTrials.gov 2026-01-28