ERAS 拉齐奥网络临床注册中心 (ENeRgy)
加速康复外科 (ERAS) 方案是旨在实施大约 25 年前制定的外科手术后患者康复的计划。 ERAS 方案基于多学科方法,包括外科、麻醉学、营养学和护理;每个专科都必须完成一些项目,这些项目已被证明可以降低发病率、住院时间并实施与标准方法相比的功能恢复。 因此,ERAS 协会制定了一系列程序的指南,包括结直肠手术。
本研究的目的是评估过去几年中罗马八个外科部门的一系列结直肠癌患者对这些方案的依从性。
次要目标是调查项目依从性与手术结果的相关性,并建立旨在在区域基础上推广 ERAS 方法的医院网络。
研究概览
详细说明
背景。 ERAS(Enhanced Recovery After Surgery)缩写,是指以患者为中心、以循证为基础的多学科方案,旨在实施围手术期手术,减少手术创伤,促进生理功能恢复,以期早日出院。
通常 ERAS 协议提供从家中开始的连续护理(入院前/入院前阶段),然后继续进行术前/术中/和术后阶段。
ERAS 包括范围广泛的学科和专家,它们专注于患者的需求,以便通过促进患者回家来改善支持。
第一个在直肠手术中引入快速通道术语的作者是 90 年代中期的 Henrik Kehlet 教授,他提出了一种旨在减少术后应激反应、发病率、死亡率和术后住院率的多模式康复计划。 从那时起,进行了多项研究,最终形成了第一个 ERAS 方案;从那时起,这些协议会定期审查,最后一次审查是在 2017 年,并包含在 ERAS 协会 (http://www.erassociety.org) 的指南中。
目前,广泛证明,与传统方法相比,ERAS 可显着降低发病率、住院天数、死亡率,实现术后早期恢复,从而降低成本,同时不会影响患者安全。
特别是用于结直肠手术的 ERAS,包括 24 个经证明的多学科。
目标。研究人员旨在评估拉齐奥地区八个中心接受结直肠切除术的连续系列患者对个别项目的依从性和短期结果(术后住院、干预后 30 天内的并发症发生率、再次干预) , 根据 ERAS 协议处理。
次要目标是调查项目依从性与手术结果的相关性,并建立旨在在区域基础上推广 ERAS 方法的医院网络。
设计。 这是一项非营利、自发、观察、非干预的审计,自 2014 年 9 月至 2017 年 10 月在拉齐奥地区的八个外科部门收集数据。 每个参与中心将保存自己的数据。
参与中心。
- UOC 普通外科 1,Fondazione Policlinico Universitario“A. Gemelli”,罗马(协调员)-
- 罗马 S. Eugenio 医院外科
- UOD Week-Day Surgery, St. Andrea Hospital, 罗马
- UOC 普外科,综合大学生物医学院,罗马
- UO 普通和紧急外科,Policlinico Casilino 医院,罗马
- UOC 外科,圣保罗医院,奇维塔韦基亚 (RM)
- UOC 普外科,Cristo Re 医院,罗马
- UOSD 普通外科机器人手术,罗马 San Giovanni-Addolorata 医院
数据采集。 每个中心都将数据收集在一个同构的数据库中。 数据将以匿名形式收集,旨在定义:
- 术后住院时间
- 根据 Clavien-Dindo 分类的短期发病率(30 天内)
- 再干预率(30天内)
- 再入院(30 天内)
F。系列项目的遵守率 所有数据都将得到明智的处理;每个患者都将被记录在一个连续的中心特定代码中。 对于所有新患者和在随访中就诊的患者,将编制研究的具体知情同意书。
统计分析。 分类变量将以比率和百分比表示,连续变量将以均值、中位数和标准差表示。
还将执行逻辑回归,将项目计算为协变量,终点为术后发病率和住院时间。
样本量计算:1000 名患者,根据每个参与中心的年度病例计算。
对于这项观察性研究的实施和管理,NHS 资金不会收取额外费用。
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Roma、意大利、00168
- Fondazione Policlinico Unversitario Agostino Gemelli
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- OLDER_ADULT
- 孩子
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
纳入标准:
- 择期结直肠手术切除
- 开放和腹腔镜手术
- 良性/恶性疾病
- 独立于年龄、性别、
排除标准:
急诊结直肠切除术
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
---|
加速术后恢复
因良性/恶性疾病而接受择期结直肠手术切除的患者。 基于入院前信息、教育和咨询等 24 项的多学科验证方法 术前优化(术前 4 周应增加运动、戒烟和饮酒) 术前无肠道准备 使用术前碳水化合物饮料 麻醉前用药 血栓栓塞预防 抗生素预防和备皮 用于快速苏醒的标准麻醉方案 PONV 微创手术 无鼻胃管引流术 预防术中体温过低 围手术期液体管理 结肠吻合术后腹膜腔内不引流 尽早去除尿液引流管(24-48 小时) 预防术后肠梗阻(包括术后泻药的使用) 术后镇痛 围手术期营养护理 术后血糖控制 早期活动 审核 |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
遵守 ERAS 协议
大体时间:36个月
|
每个中心应用的 ERAS 协议中包含的项目数
|
36个月
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
ERAS 方案的项目数与 Clavien Dindo 分类所描述的不良事件相关,并且与住院时间更长相关
大体时间:36个月
|
将 ERAS 项目与发病率或住院时间延长相关联的多变量分析(> 平均值)
|
36个月
|
合作者和调查者
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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