A Randomized Controlled Study of Minimal Access Latissimus Dorsi Flap Harvest for Breast Reconstruction Versus Conventional Approaches in the Treatment of Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Breast Q-satisfaction with back
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with early-stage breast cancer between the ages of 18 and
- •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.
排除标准
- •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.
结局指标
主要结局
Breast Q-satisfaction with back
时间窗: 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.
次要结局
- Patient satisfaction(6 months)
- Postoperative pain(Perioperative)
- Latissimus dorsi acquisition time(Perioperative)
- Intraoperative blood loss(Perioperative)
- Postoperative complications(6 months)