Fast Track Protocol After Radical Cystectomy and Urinary Diversion: A Randomised Controlled Trial.
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Length of hospital stay.
研究概览
简要总结
We will design a randomized controlled single center study in which we will compare 2 groups of patients, 1 with standard perioperative protocols and another one in which we will apply fast track protocols in patients after radical cystectomy and urinary diversion .
详细描述
Study hypothesis:
Fast Track Protocol after Radical Cystectomy reduces the length of hospital stay and the early postoperative complications relative to the traditional perioperative care regimen.
Purpose of the study:
- To evaluate the the perioperative efficacy, safety and benefits of fast track protocol implementation after radical cystectomy and to optimize perioperative patient care for the benefit of "fast-track" surgery.
- To evaluate early complications in patients with bladder cancer who will be subjected to radical cystectomy and urinary diversion.
Study groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing radical cystectomy and urinary diversion surgery including orthotopic neobladder and ileal loop conduit
排除标准
- •Radical cystectomy performed in an emergency setting
- •Patients who refused fast track protocol
- •Mental illnesses
研究组 & 干预措施
Fast Track Protocol
the 22 items of ERAS (Early Recovery After Surgery) society
干预措施: Fast Track Protocol (Behavioral)
Conventional perioperative care program
standard perioperative care
结局指标
主要结局
Length of hospital stay.
时间窗: 3 months after surgery.
Mean length of hospital stay defined as days from admission to the hospital, in both groups 1 day before surgery and discharge.
次要结局
- Early postoperative complications rate defined and graded according to Clavien-Dindo system.(3 months after surgery.)
- Hospital readmission rate.(3 months after surgery.)
研究者
Ahmed Mohammed Lashin
A.M.Lashin
Mansoura University