跳至主要内容
临床试验/NCT02126813
NCT02126813已完成不适用

Urinary Bladder Catheterization in Fast-track Hip and Knee Arthroplasty - What is the Optimal Bladder Volume? A Randomized, Controlled Study

Rigshospitalet, Denmark6 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2014年5月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lars Bjerregaard

M.D.

Rigshospitalet, Denmark

研究点 (6)

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