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临床试验/NCT04954443
NCT04954443已完成不适用

Urinary Retention After Removing Urinary Catheter at 24 Hour Comparison With 48 Hour in Patients With Vaginal Surgery of Pelvic Organ Prolapse, Randomized Controlled Trial

Rajavithi Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Urinary retention

研究概览

简要总结

Comparison incident of urinary retention in patients with vaginal surgery of pelvic organ prolapse, who removed urinary catheter at 24 hours versus 48 hours after surgery

详细描述

Vaginal surgery of pelvic organ prolapse needs to insert urinary catheter for monitoring post-operative complication, hemodynamic status, and prevention post-operative urinary retention. Urinary retention occur 2.4 - 43% after pelvic organ prolapse surgery, whereas retaining urinary catheter is common cause of urinary tract infection, often hospital-acquired infection. At Rajavithi hospital always remove urinary catheter at 48 hour after surgery. Accordingly, appropriated time for removing urinary catheter in patients with vaginal surgery of pelvic organ prolapse is unclear. This study aims to reduce timing for removing urinary catheter after vaginal surgery, not increase urinary retention and re-catheterization and reduce urinary tract infection and day of hospital stay.

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
Double (Care Provider, Investigator)

盲法说明

Single blind (Care provider, investigator)

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Woman with pelvic organ prolapse, who undergoing vaginal surgery and agrees to participate in this study
  • Able to understand and communicate Thai language

排除标准

  • Woman with diabetes mellitus with HbA1C > 10.9%
  • Woman with stroke
  • Woman with urinary tract infection before surgery
  • Woman with urinary retention before surgery
  • Woman, who experienced surgery for urinary incontinence
  • Woman, with operative complication including of hemorrhagic shock (Blood pressure < 90/60 mmHg, Heart rate > 120 beats per minute, Intra-operative blood loss > or = 750 ml), urinary tract injury, bowel injury

结局指标

主要结局

Urinary retention

时间窗: Through study completion, an average of 1 year

Incident of urinary retention (Post-void residual urine at least 150 ml) after removing urinary catheter at 24 hour comparison with 48 hour after vaginal surgery of pelvic organ prolapse

次要结局

  • Urinary tract infection(Through study completion, an average of 1 year)
  • Re-catheterization after removing urinary catheter(Through study completion, an average of 1 year)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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