Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction

NCT06319157 · tracked via the Priya Life Science China tracker

Sponsor

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

Phase

Not applicable

Started

2024-03

Last updated

2024-03-19

Condition(s) studied

Breast Neoplasms

Investigational drug(s) / intervention(s)

minimal access breast reconstruction with a latissimus dorsi muscle flapconventional breast reconstruction with a latissimus dorsi muscle flap

minimal access breast reconstruction with a latissimus dorsi muscle flap: minimal access breast reconstruction with a latissimus dorsi muscle flap

conventional breast reconstruction with a latissimus dorsi muscle flap: conventional breast reconstruction with a latissimus dorsi muscle flap

Study 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

FEMALE

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: 1. Female patients with early-stage breast cancer between the ages of 18 and 70. 2. Breast cancer was confirmed by histology or biopsy. 3. Breast-conserving surgery or multifocal breast cancer or large unifocal breast cancer (\<5cm) can be accepted. 4. After neoadjuvant therapy, large monofocal carcinoma (\>5 cm) confined to the breast shrunk to \<5 cm. 5. No chest wall, cutaneous or NAC invasion (including Paget's disease). 6. Mild to moderate breast sagging, and the patient has the willingness to undergo autologous reconstruction of the latissimus dorsi. 7. There is no need to obtain additional back skins. 8. Willing to participate and able to complete follow-up and evaluation during the study. Exclusion Criteria: 1. Patients with advanced breast cancer (stage III and above) or metastatic breast cancer or inflammatory breast cancer. 2. The risk of recurrence is expected to be high. 3. History of thoracic and dorsal vascular injury. 4. Patients with severe heart, lung, or liver disease who cannot withstand surgery and anesthesia. 5. Patients with active infection or severe immune system disease. 6. Patients with severe allergic reactions to materials related to latissimus dorsi muscle flap transplantation. 7. Patients with other major surgeries or reconstructive surgeries planned for the near future. 8. Patients with cognitive dysfunction or psychiatric disorders who cannot understand and cooperate with the requirements of the study. 9. Patients who refuse to participate in the study or are unable to complete follow-up and evaluation during the study.

Primary outcome measure(s)

Breast Q-satisfaction with back — 6 months
Patient satisfaction with the back, assessed using the Breast Q-satisfaction with back subscale. 6 months after surgery, the doctor provided each patient with a Breast Q-satisfaction with back questionnaire, and asked the patient to fill in the questionnaire truthfully, and each questionnaire took 1-4 minutes to complete. Before each questionnaire is completed, the doctor will give the patient a simple guide to make it clear what each option means.

Trial sites (1)

Facility	City	Region	Status
Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06319157 on ClinicalTrials.gov ↗ ← All trials in China