NCT06319157

Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction

A Randomized Controlled Study of Minimal Access Latissimus Dorsi Flap Harvest for Breast Reconstruction Versus Conventional Approaches in the Treatment of Early Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DEVICE	minimal access breast reconstruction with a latissimus dorsi muscle flap	minimal access breast reconstruction with a latissimus dorsi muscle flap
DEVICE	conventional breast reconstruction with a latissimus dorsi muscle flap	conventional breast reconstruction with a latissimus dorsi muscle flap

Timeline

• Start date: 2024-03-01
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2024-03-19
• Last updated: 2024-03-19

Locations

1 site across 1 country: China