KCT0007592尚未招募未知
A Prospective Multicenter Randomized Clinical Trial: Robot-assisted vs. Open nipple-sparing Mastectomy with Immediate Breast Reconstruction (ROM) trial
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 790
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1. Adult women over the age of 19 with breast cancer scheduled for therapeutic mastectomy and who want immediate reconstruction
- •2. Stage 0-III breast cancer at initial evaluations
- •3. ECOG performance status of 0 or 1
排除标准
- •- Patients planned for breast-conserving surgery or who are not candidates for IBR are excluded.
- •- Clinical evidence for nipple or skin involvement of tumors in preoperative evaluations
- •- A pregnant or lactating woman
- •- Only tumors with lobular carcinoma in situ
- •- Mammary Paget’s disease
- •- Inflammatory breast cancer
- •- Male breast cancer
- •- Stage IIIB-IV disease at initial presentation
- •- Women with breast Cup E or higher
- •- Previous history of breast cancer (metachronous breast cancer)
- •- Previous history of non-mammary malignant disease excluding non-melanoma skin cancer or thyroid papillary/follicular cancer
- •- Special type cancer (phyllodes tumor, sarcoma, and lymphoma)
- •- Age > 70
- •- ASA, grade 4 or higher
- •- Patients who do not have the ability to give informed consent
- •- Previous thoracic radiation history
- •- Patients who have not been tested for hepatitis before surgery (HBV, HCV) an
研究者
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