跳至主要内容
临床试验/CTRI/2019/05/019394
CTRI/2019/05/019394尚未招募不适用

A Randomised controlled trial comparing post-operative outcomes of patients planned for non descent vaginal hysterectomy with or without indwelling foleys catheter

Government health schemes1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Positive urine cultureo( at least 105 colony forming units of an identified single uropathogen per millilitre )

研究概览

简要总结

The use of an indwelling catheter for the first 24 hours after routine hysterectomy has been based on custom with no evidence based support. Indwelling urinary catheter associated with a higher incidence of symptomatic urinary tract infections, post operative pyrexia, catheter associated pain,delayed ambulation time  and longer hospital stay however more chances of retention of urine in case of no indwelling catheter.So this study is designed for comparing post operative outcomes of patients planned for NDVH with or without indwelling foleys catheter

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
35.00 Year(s) 至 80.00 Year(s)(—)
性别
Female

入选标准

  • NDVH for benign gynecological indications Vaginal hysterectomy with no obvious prolapse or <1 degree prolapse.

排除标准

  • Vaginal hysterectomy for pelvic organ prolapse (POP) Suspected malignancy Diagnosis suspicious for endometriosis Large tubo-ovarian absess Ovarian cysts Previous pelvic surgery by abdominal approach Pelvic inflammatory disease Extensive vaginal discharge Local vaginal or cervical infection Positive pre-operative urine culture Known history of neurological disorder Patient with recurrent UTI.

结局指标

主要结局

Positive urine cultureo( at least 105 colony forming units of an identified single uropathogen per millilitre )

时间窗: Urine specimen will be obtained on the postoperative day 2 and 2 week after surgery for culture and sensitivity

Symptomatic UTI

时间窗: Urine specimen will be obtained on the postoperative day 2 and 2 week after surgery for culture and sensitivity

Re-catheterization

时间窗: Urine specimen will be obtained on the postoperative day 2 and 2 week after surgery for culture and sensitivity

Post-operative pyrexia

时间窗: Urine specimen will be obtained on the postoperative day 2 and 2 week after surgery for culture and sensitivity

次要结局

  • Catheter associated pain(Duration of hospital stay)

研究者

发起方
Government health schemes
申办方类型
Government medical college

研究点 (1)

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