A Multicenter, Open and Prospective Randomized Controlled Trial Comparing the Safety and Cosmetic Outcomes of Laparoscopic Breast-conserving Surgery Versus Traditional Open Breast-conserving Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- breast appearance satisfaction
研究概览
简要总结
In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.
详细描述
In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required to ensure the efficiency of cure. Also, less scars and breast preservation has becoming more and more important for patients' acceptance to the treatment. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female over the age of 18
- •Preoperative pathologically confirmed invasive breast cancer or ductal carcinoma in situ
- •Clinical classification T1, T2 (maximum tumor diameter ≤5cm)
- •Single-center tumor (preoperative confirmation by B-ultrasound, MRI and other imaging examinations)
- •No clinical or imaging evidence of distant metastasis
- •Able and willing to sign informed consent
排除标准
- •Tumor in the lower inner quadrant
- •Tumor in multiple quadrants
- •Imaging or intraoperative pathology indicates tumor invasion of the nipple areola, skin, or pectoralis major
- •Locally advanced breast cancer patients are undergoing neoadjuvant therapy
- •Tumor in multiple quadrants
- •Have been participating in other clinical trials, which may affect the participation in this trial
- •Previous history of breast cancer (patients with recurrence after ipilateral breast-conserving surgery)
- •Pregnant and lactating women
- •Patients with severe cardiopulmonary disease or severely impaired lung function are not suitable for surgical establishment of an air cavity
研究组 & 干预措施
Laparoscopic breast-conserving surgery
Subjects who is going to accept laparoscopic breast-conserving surgery.
干预措施: Laparoscopic breast-conserving surgery (Procedure)
Traditional open breast-conserving surgery
Subjects who is going to accept traditional open breast-conserving surgery.
干预措施: Traditional open breast-conserving surgery (Procedure)
结局指标
主要结局
breast appearance satisfaction
时间窗: 2 years
Whether laparoscopic breast-conserving and traditional open breast-conserving had significant differences postoperative cosmetic outcomes. One of the evaluation indicators is breast appearance satisfaction. Our study chooses BREAST-Q questionnaire to evaluate patients' breast appearance satisfaction.
breast aesthetic scores
时间窗: 2 years
Whether laparoscopic breast-conserving and traditional open breast-conserving had significant differences postoperative cosmetic outcomes. Another of the evaluation indicators is breast aesthetic scores. We will invite two Plastic surgeons who did not participate in the study to judge patients' photographs, which is taken 18 months after the surgery, according to the Harris evaluation criteria.
次要结局
- Quality of Life(1 year)
- Complications(1 year)
- local recurrence rate(2 years)