Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction - Trial NCT06319157
Access comprehensive clinical trial information for NCT06319157 through Pure Global AI's free database. This phase not specified trial is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University and is currently Recruiting. The study focuses on Breast Neoplasms. Target enrollment is 94 participants.
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Study Focus
minimal access breast reconstruction with a latissimus dorsi muscle flap
Interventional
device
Sponsor & Location
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Timeline & Enrollment
N/A
Mar 01, 2024
Nov 01, 2028
Primary Outcome
Breast Q-satisfaction with back
Summary
For patients refusing implants for breast reconstruction after cancer surgery, autologous
 tissue flap reconstruction using the latissimus dorsi muscle is an alternative. Conventional
 surgery leaves a long incision on the back, affecting aesthetics and quality of life. Minimal
 access techniques result in a smaller, more concealable scar. While previous studies suggest
 its safety and effectiveness, most are retrospective. To further validate patient
 satisfaction and short-term outcomes, a prospective, randomized controlled trial comparing
 minimal access with conventional surgery is planned. The primary endpoint is Breast
 Q-satisfaction with back score at 6 months. Secondary outcomes include other Breast Q
 subscales, surgical metrics, and complications. The study aims to enroll 94 patients in
 total, providing evidence for surgical decision-making in breast cancer reconstruction.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06319157
Device Trial