A Retrospective Analysis of Robot-Assisted Versus Endoscopic Breast-Conserving Surgery for Breast Cancer
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sixth Affiliated Hospital, Sun Yat-sen University
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Postoperative complication rate
概览
简要总结
Robotic surgical systems provide notable advantages including enhanced dexterity, a magnified three-dimensional high-definition view, and high-resolution imaging, thereby improving operative stability and precision. These features make robotic systems particularly suitable for procedures performed within confined operative spaces. As the breast is a solid organ without a natural cavity, robotic systems demonstrate strong adaptability for breast surgery. Robot-assisted breast-conserving surgery (RABCS) is one of the currently utilized robotic techniques in clinical breast cancer surgery. However, as robotic breast surgery remains in its early stage of development, evidence regarding the clinical outcomes of RABCS remains limited in the literature. Therefore, this study compares the surgical outcomes of endoscopic breast-conserving surgery and robot-assisted breast-conserving surgery in breast cancer patients, aiming to assess and elucidate the clinical value of RABCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 to 80 years
- •Pathologically confirmed breast cancer prior to surgery
- •Sufficient glandular volume with a tumor-to-breast volume ratio ≤20%
- •A unifocal lesion confined to the glandular tissue
- •Clear desire for breast conservation and willingness to undergo R-BCS or E-BCS
- •No evidence of distant metastasis, no involvement of the skin or chest wall
- •Eligibility for standard postoperative radiotherapy
排除标准
- •The presence of diffuse suspicious lesions or microcalcifications for which wide local resection was unlikely to achieve adequate negative margins or satisfactory aesthetic outcomes
- •Bilateral breast cancer or inflammatory breast cancer
- •After neoadjuvant therapy, requirement for additional concurrent surgical procedures
- •Inability to tolerate general anesthesia or undergo surgery
- •Contraindications to radiotherapy or a history of prior chest wall irradiation, pregnancy- or lactation-associated breast cancer
- •Refuse to undergo R-BCS or E-BCS
研究组 & 干预措施
Robotic breast-conserving surgery
干预措施: Robotic breast-conserving surgery (Procedure)
Endoscopic breast-conserving surgery
干预措施: Endoscopic breast-conserving surgery (Procedure)
结局指标
主要结局
Postoperative complication rate
时间窗: 1 month postoperatively
次要结局
- Operation time(Intraoperative)
- Aesthetic outcomes(3 month postoperatively)
- Blood loss(Perioperative)
研究者
Haiyan Li
chief physician
Sixth Affiliated Hospital, Sun Yat-sen University