RecruitingNot ApplicableNCT06319157

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

Sponsor

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

Enrollment

94 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study compares two surgical methods for harvesting a muscle flap (called a latissimus dorsi flap) used to reconstruct the breast after breast cancer surgery. One method uses a small incision (minimal access) and the other uses a traditional larger incision, comparing outcomes like scarring, recovery time, and complications. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have been diagnosed with early-stage breast cancer confirmed by biopsy - You are having breast-conserving surgery, or you have multifocal or large breast cancer (under 5 cm) - If you had treatment before surgery, your tumor has shrunk to under 5 cm - There is no invasion of the chest wall, skin, or nipple **You may NOT be eligible if...** - You have advanced breast cancer with spread to distant sites - You have had prior surgery or trauma to the back area used for the flap - You are pregnant - You have conditions that make surgery too risky Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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