Enhanced Recovery After Radical Cystectomy Study
研究概览
详细说明
This is a prospective non randomized study of two cohorts, one defined by the usual protocol and the other one by the application of accelerated recovery protocol. It's discarded a priori a prospective randomized trial, since it does not seem feasible to avoid byass of control group when synchronizing the active intervention and control. Subjects surgery will be followed after discharge for a minimum of 90 days, and thereafter according to protocol of each center. Patients will be provided with a satisfaction survey 90 days after surgery.
The degree of compliance with the protocol will be assessed through a checklist indicating compliance with each of the steps of the protocol in both groups. All patients will sign an informed consent for the study authorizing the use of their clinical data for statistical analysis.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Madrid、西班牙
- Fundación Jiménez Díaz
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Madrid、西班牙
- Hospital Doce de Octubre
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Madrid、西班牙
- Hospital Infanta Leonor
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Madrid、西班牙
- Hospital Universitario Gregorio Marañón
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Madrid
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Alcalá de Henares、Madrid、西班牙
- Hospital Universitario Príncipe de Asturias
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Alcorcón、Madrid、西班牙
- Hospital Universitario Fundacion ALcorcon
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Getafe、Madrid、西班牙
- Hospital Universitario de Getafe
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Leganés、Madrid、西班牙
- Hospital Universitario Severo Ochoa
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Majadahonda、Madrid、西班牙
- Hospital Puerta de Hierro
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Móstoles、Madrid、西班牙
- Hospital Universitario Rey Juan carlos
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Torrejón de Ardoz、Madrid、西班牙
- Hospital Universitario de Torrejón
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Valdemoro、Madrid、西班牙
- Hospital Universitario Infanta Elena
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参与标准
资格标准
适合学习的年龄
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
Inclusion Criteria:
- Consecutive patients scheduled for radical cystectomy in the participating hospitals
- Signed informed consent
Exclusion Criteria:
- Refusal to sign informed consent
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
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Control
Consecutive radical cystectomies up to 94 patients in 13 participating hospitals in Madrid, Spain.
These patients will be taken care of as it is done regularly in each of participating hospitals.
All study variables will be prospectively collected in this group
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Active Treatment
After recruiting cotrol group, another consecutive radical cystectomies up to 94 patients in 13 participating hospitals will be recruited and the following measures will be followed with them: I.-PREOPERATIVE MEASURES: (eight measures according to Protocol) II.- INTRAOPERATIVE MEASURES: (six measures according to Protocol) III.- POSTOPERATIVE MEASURES: (eight measures according to Protocol) |
Pre-, intra- and post-operative clinical measures during radical cystectomy clinical process
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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 |
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In-hospital length-of-stay (LOS), defined as the number of days since the admission of the patient to the hospital until the day of discharge, Morbidity of surgery. Categorized by the Clavien complications scale at 30-, 60- and 90-postoperative days
大体时间：5-40 days
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Day 1: Admission to the hospital Last day of accountant: Discharge from the hospital or death in the hospital.
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5-40 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mortality at 30-, 60- and 90- postoperative days
大体时间：90 days
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90 days
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30 天再入院率
大体时间：30天
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30天
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Transfusion rate
大体时间：90 days
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90 days
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Patient satisfaction measured with the enclosed questionnaire
大体时间：90 days
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Do you know the names of your attending physician and nurse? The quality of the preoperative care and information has been: The quality of the postoperative care and information has been: Do you think that the information on the care of your urostomy has been enough? Yes/No If NO, on which of the following points would you have liked receiving more information? Types of collecting bags and accessories Stomal hygiene and change of bags Complications of the stoma and the surrounding skin Counseling on food habits, dress apparel, and physical and sexual activity Comunity counselling: Stoma therapist, patients associations If you had a neobladder performed, were you trained in self-catheterization ? How would you rate your motivation in learning the above mentioned issues? In all, the quality of the health care that you have received is: |
90 days
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合作者和调查者
调查人员
- 首席研究员：Carlos Llorente, MD、Hospital Fundación de Alcorcón
研究记录日期
研究主要日期
学习开始
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 (估计)
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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