Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction

Sun Yat-sen University

Status: Enrolling

Conditions: Breast Neoplasms

Treatments: Device: minimal access breast reconstruction with a latissimus dorsi muscle flap; Device: conventional breast reconstruction with a latissimus dorsi muscle flap

Study type: Interventional

Funder types: Other

Identifiers

NCT06319157

SYSKY-2023-1263-02

Details and patient eligibility

About

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.

Enrollment: 94 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

minimal access group

Experimental group

Treatment:

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

conventional group

Other group

Treatment:

Device: conventional breast reconstruction with a latissimus dorsi muscle flap