Enhanced Recovery After Radical Cystectomy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 241
- 试验地点
- 12
- 主要终点
- 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
研究概览
简要总结
Prospective non randomized study of two cohorts: usual protocol and the application of accelerated recovery protocol. F/up after discharge, 90 days and thereafter according to protocol of each center. Compliance to be assessed.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients scheduled for radical cystectomy in the participating hospitals
- •Signed informed consent
排除标准
- •Refusal to sign informed consent
结局指标
主要结局
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
时间窗: 5-40 days
Day 1: Admission to the hospital Last day of accountant: Discharge from the hospital or death in the hospital.
次要结局
- Transfusion rate(90 days)
- 30-day readmission rate(30 days)
- Mortality at 30-, 60- and 90- postoperative days(90 days)
- Patient satisfaction measured with the enclosed questionnaire(90 days)
研究者
Carlos Llorente
Doctor in Medicine
Hospital Universitario Fundación Alcorcón