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RECRUITING
NCT06319157
NA

Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction

Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2024-03

Completion Date

2028-11

Last Updated

2024-03-19

Healthy Volunteers

No

Interventions

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

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China