Urinary Bladder Catheterization in Fast-track Hip and Knee Arthroplasty - What is the Optimal Bladder Volume? A Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 6
- 主要终点
- Number of patients receiving postoperative urinary bladder catheterization
研究概览
简要总结
Approximately 40 % of all patients undergoing fast-track total hip or knee arthroplasty needs intermittent bladder catheterization after surgery, as they are transient incapable of voluntary bladder emptying (postoperative urinary retention - POUR). The currently used interventional threshold for urinary bladder catheterization are a bladder volume of approximately 500 ml., but no evidence exists for this threshold. At the same time, the current knowledge suggest, that a bladder volume up to 1000 ml. for 2-4 hours are safe in humans, and as the use of urinary bladder catheterization are increasing the risk of complications, the investigators are hypothesizing that increasing the interventional threshold for urinary bladder catheterization after fast-track total hip or knee arthroplasty, will reduce the number of patients needing urinary bladder catheterization, without increasing the incidence of urological complications - including urinary tract infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 125 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •planned for elective total hip or knee arthroplasty
- •given written informed consent for participation
排除标准
- •can't co-operate to participation
- •can't speak or understand danish
- •preoperative use of urinary bladder catheterization
- •using haemodialysis
- •previous cystectomy
- •need for permanent urinary bladder catheter during surgery (decided by anaesthesiologist and/or surgeon)
- •Pregnant or given birth within the last 6 months
结局指标
主要结局
Number of patients receiving postoperative urinary bladder catheterization
时间窗: Patients will be followed from end of surgery to their first voluntary micturition, expectably within a mean period of twelve hours
次要结局
- Number of readmissions due to urological issues (including urosepsis)(Within the first 30 days postoperatively)
- Number of voiding difficulties acquired postoperatively(within the first 30 days postoperatively)
- Incidence of urinary tract infections(within the first 30 days after surgery)
研究者
Lars Bjerregaard
M.D.
Rigshospitalet, Denmark
