A Comparative Study of Delayed Endoscopic DTI and Autologous Flap Reconstruction Post-Mastectomy

In China, low breast-conserving surgery rates and historically minimal immediate reconstruction following mastectomy have resulted in a significant population of women living without a breast, often leading to long-term psychosocial distress. Current delayed reconstruction options are limited: traditional two-stage implant reconstruction necessitates two surgeries with associated costs and risks like infection and implant exposure, while autologous tissue transfer (e.g., TRAM/DIEP flaps), though offering superior natural aesthetics and patient satisfaction, involves extensive donor-site morbidity, prolonged recovery, and significant scarring, restricting its suitability. To address the drawbacks of both established methods-significant trauma, cost, and complexity-this study evaluates a novel technique for breast cancer patients post-mastectomy: endoscopic delayed direct-to-implant breast reconstruction. This study proposes to conduct a prospective cohort study to analyze complication rates, breast aesthetic scores, quality of life metrics, and other dimensions between delayed direct-to-implant breast reconstruction and abdominal flap breast reconstruction（DIEP and TRAM). The aim is to comprehensively evaluate the safety and clinical feasibility of endoscopic delayed direct-to-implant breast reconstruction.

NCT Number	NCT07602868
Lead Sponsor	West China Hospital Collaborators: Hunan Cancer Hospital, West China Fourth Hospital, West China Second University Hospital
Conditions	Breast Reconstruction After Mastectomy
Enrollment	263 participants
Start Date	2026-09-01
Primary Completion	2028-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-04