Robotic-assisted Left Hemicolectomy for Left Colon Cancer
赞助:
Southwest Hospital, China
合作者:
信息的提供 (责任方):
Li Chuan，Southwest Hospital, China
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | April 24, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | December 2018 | ||
| 预计主要完成日期 | November 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
5-years overall survival rate[ Time Frame: 5 years ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Robotic-assisted Left Hemicolectomy for Left Colon Cancer | ||
| 正式标题 ICMJE | Robotic-assisted Left Hemicolectomy for Left Colon Cancer With a Medial-to-lateral Approach Orientated by AMA or AMV | ||
| 简要概况 | The main goal of this study is to clarify if Robotic-assisted surgery could become the standard approach in patients undergoing left colonic resection. Patient candidates to left colonic resection were randomly assigned to Robotic(RAL) or laparoscopic(LL) approach. The surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital days. Long-term morbidity, quality of life, and 5-year survival have also been evaluated |
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| 详细说明 | Robotic-assisted Left Hemicolectomy as advantages on showing the inferior mesenteric artery (IMA), protection of autonomic nerve compare to laparoscopic approach. Our experience found that operational flexibility was advantage without surgeon's position exchange. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
2 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 2020 | ||
| 预计主要完成日期 | November 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: Agreement of the patient to participate in trial Colon cancer (only adenocarcinoma ) The tumor located between the descending colon and the right 1/3 of transverse colon Tumors T3,Т4а,b N0-2 (II-III stages) Tolerance of chemotherapy ECOG 0-2 Exclusion Criteria: Patients with distant metastases Tumors T1-2 (I stage) Complications of tumor (perforation and full bowel obstruction) Previous radiotherapy or chemotherapy Synchronous or metachronous tumors Women during Pregnancy or breast feeding period Unable to go through the treatment because of family, society or regional condition | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：75 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | China | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Li Chuan，Southwest Hospital, China | ||
| 研究赞助商 ICMJE | Southwest Hospital, China | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Southwest Hospital, China | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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