Critical View of Safety in Laparoscopic Cholecystectomy
赞助:
Assiut University
合作者:
信息的提供 (责任方):
Abanoub Khalf Henry Romany，Assiut University
| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 20, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | October 1, 2018 | ||
| 预计主要完成日期 | October 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
(CVS) is a mean of target identification, the targets being the cystic duct and artery for changes in the incidence of biliary injury. Identifying the common bile duct as the cystic duct is the commonest cause of major bile duct injury.[ Time Frame: baseline & 6 months ] Identifying the common bile duct as the cystic duct is the commonest cause of major bile duct injury. Active identification of cystic structures within Calot's triangle is the key to a reduction in biliary injury. To fulfil the criteria for a CVS requires Calot's triangle to be cleared free of fat and fibrous tissue ('fat cleared'), for the lowest part of the gallbladder to be dissected free from the cystic plate ('liver visible') and for there to be only two structures entering the gallbladder ('2 structures'). |
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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 | Critical View of Safety in Laparoscopic Cholecystectomy | ||
| 正式标题 ICMJE | Assessment of Routine Use of Critical View of Safety in Laparoscopic Cholecystectomy, Prospective Cohort Study | ||
| 简要概况 | This prospective cohort study aims to assess feasibility and safety of the approach of critical view of safety during laparoscopic cholecystectomy |
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| 详细说明 | Since the introduction and routine use of laparoscopic cholecystectomy in the 1990s, the reported incidence of biliary injuries has doubled to 0.4%. Many factors have been shown to influence the risk of biliary injury including patient factors (obesity, older age, male gender and adhesions), local factors (severe gallbladder inflammation/infection, aberrant anatomy and haemorrhage) as well as surgeon experience. Identifying the common bile duct as the cystic duct is the commonest cause of major bile duct injury Active identification of cystic structures within Calot's triangle is the key to a reduction in biliary injury. Strasberg first coined the term 'critical view of safety' (CVS) in 1958 and this approach of identification of cystic structures has been adopted by many surgeons as the standard of operative technique to reduce the incidence of biliary injury. To fulfil the criteria for a CVS requires Calot's triangle to be cleared free of fat and fibrous tissue ('fat cleared'), for the lowest part of the gallbladder to be dissected free from the cystic plate ('liver visible') and for there to be only two structures entering the gallbladder ('2 structures'). The published rate of bile duct injury with this approach is very low However more studies are needed to assess risk benefit rate of this approach. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group 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 |
50 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 2019 | ||
| 预计主要完成日期 | October 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - include all patients who will have laparoscopic cholecystectomy Exclusion Criteria :- - Emergency laparoscopic cholecystectomy - Liver cirrhosis - HCV & HBV | ||
| 性别 |
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| 年龄 | 最小年龄：N/A ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | ||
| 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 | Abanoub Khalf Henry Romany，Assiut University | ||
| 研究赞助商 ICMJE | Assiut University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Assiut University | ||
| 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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