Prospective Cohort Study of Mastectomy With Reconstruction Including Robot Endoscopic Breast Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 试验地点
- 18
- 主要终点
- Postoperative complication rates in 30 days
研究概览
简要总结
Robotic mastectomy and immediate reconstruction have been introduced in 2015. However, since robotic mastectomy is the latest surgical technique, there is a lack of studies prospectively comparing conventional mastectomy and immediate reconstruction with robotic mastectomy. For this reason, this study is designed to establish a single institution cohort study that prospectively collects patients undergoing mastectomy and reconstruction. This study was initially designed as a single institution study, however, currently, the study was extended to the multicenter study including 18 institutions over the country. Using the established prospective cohort data, a comparative study of robotic mastectomy with conventional mastectomy and reconstruction, and cost-effectiveness and satisfaction of robotic endoscopic surgery, and cost-effectiveness and satisfaction of reconstructive surgery are to be analyzed.
详细描述
This study is a multi-institution cohort study that prospectively collects patients undergoing mastectomy and reconstruction.
Patients' inclusion criteria is as below; adult women between the ages of 19 and 80, with breast cancer or high risk of breast cancer (patients with a BRCA1/2 mutation, TP53 mutation, PALB2 mutation, etc) scheduled for therapeutic or prophylactic mastectomy, and want immediate reconstruction.
Patients planned for breast-conserving surgery or who do not want immediate reconstruction will be excluded. Patients who planned for surgery on both sides in the different methods (e.g. right for RNSM and left for conventional open NSM) are also excluded. Meanwhile, cases with ipsilateral NSM and contralateral partial mastectomy or excision are included.
The goal number of enrolled patients is 2000.
Collecting data includes patients' clinicopathological factors including height, weight, etc. And also collecting surgical results, oncological results, cost-effectiveness, and satisfactions of patients to secure high-level data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient between the ages of 19 and 80
- •Patients with breast cancer or high risk of breast cancer ( BRCA1/2 mutation, TP53 mutation, PALB2, etc.)
- •Patients scheduled for therapeutic or prophylactic mastectomy (including conventional mastectomy, skin sparing mastectomy, areolar conserving mastectomy)
- •Patients who want immediate reconstruction during mastectomy
- •Those agreed in writing consent to participate study
排除标准
- •Patients scheduled for breast conserving mastectomy
- •Patients who do not want immediate reconstruction during mastectomy
- •Patients who planned for surgery on both sides in the different methods
结局指标
主要结局
Postoperative complication rates in 30 days
时间窗: Postoperative 30 days
Postoperative complication rates are calculated as total number of postoperative complication cases per total operation cases.
Clavien-Dindo grade of postoperative complications
时间窗: Postoperative 180 days
Clavien-Dindo grade of postoperative complications is evaluated. The highest grade of postoperative complications are used for the analysis.
次要结局
- Patient's satisfaction (about reconstruction expectations)(within preoperative 4 weeks to operation and within postoperative 6 month to 12 month.(Patients who have undergone skin sparing mastectomy can do within up to 3 years))
- Surgeon's satisfaction(Postoperative 6 month to 12 month(Patients who have undergone skin sparing mastectomy can do within up to 3 years)
- Cost-effectiveness(Postoperative 6 month to 1 year(Patients who have undergone skin sparing mastectomy can do within up to 3 years)
- Recurrence free survival (RFS)(Postoperative 5 years)
- Cancer incidence rate(Postoperative 5 years)
- Patient's satisfaction (about reconstruction results)(within preoperative 4 weeks to operation and within postoperative 6 month to 12 month.(Patients who have undergone skin sparing mastectomy can do within up to 3 years))
研究者
Hyung Seok Park, MD, PhD
Professor
Severance Hospital