Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction

Recruiting now · Not applicable

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT06319157

Run by

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

People needed

94

Starts

2024-03-01

Expected to finish

2028-11-01

Last updated by the study team

2024-03-19

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients with early-stage breast cancer between the ages of 18 and 70.
• Breast cancer was confirmed by histology or biopsy.
• Breast-conserving surgery or multifocal breast cancer or large unifocal breast cancer (<5cm) can be accepted.
• After neoadjuvant therapy, large monofocal carcinoma (>5 cm) confined to the breast shrunk to <5 cm.
• No chest wall, cutaneous or NAC invasion (including Paget's disease).
• Mild to moderate breast sagging, and the patient has the willingness to undergo autologous reconstruction of the latissimus dorsi.
• There is no need to obtain additional back skins.
• Willing to participate and able to complete follow-up and evaluation during the study.

You may not qualify if…

• Patients with advanced breast cancer (stage III and above) or metastatic breast cancer or inflammatory breast cancer.
• The risk of recurrence is expected to be high.
• History of thoracic and dorsal vascular injury.
• Patients with severe heart, lung, or liver disease who cannot withstand surgery and anesthesia.
• Patients with active infection or severe immune system disease.
• Patients with severe allergic reactions to materials related to latissimus dorsi muscle flap transplantation.
• Patients with other major surgeries or reconstructive surgeries planned for the near future.
• Patients with cognitive dysfunction or psychiatric disorders who cannot understand and cooperate with the requirements of the study.
• Patients who refuse to participate in the study or are unable to complete follow-up and evaluation during the study.

Where it is running

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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