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临床试验/CTRI/2018/11/016299
CTRI/2018/11/016299尚未招募2 期

A randomized controlled trial comparing early versus late catheter removal after radical hysterectomy

FLUID RESEARCH GRANT1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年11月11日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Urinary infection rate

研究概览

简要总结

Radical hysterectomy is the primary mode of therapy for early stage cervical cancer.Urinary tract complications are common following radical hysterectomy.These include prolonged bladder dysfunction resulting in urinary retention ,diminished bladder sensation ,urinary infection and fistula formation.The etiology of these comlicaions is thought to be due to the extensive dissection during the procedure leading to sensory or motor abnormalities of the detrusor muscle or a combination of both which can be exacerbated by the local haematoma, edema, and fibrosis.However the pathophysiology of bladder dysfunctiion remains poorly understood.Decreased bladder sensation and urinary retention are observed in some women requiring prolonged bladder catheterisation, intermittent self catheterisation, or supra pubic pressure to empty the bladder completely.Prolonged bladder catheterisation is a cornerstone of post operative managementafter radical hysterectomy with a view to prvent these bladder complications.

The incidence of bladder dysfunction after radical hysterectomy varies from 12% to 85% depending on the method used in the evaluation of bladder dysfunction, duration of follow up. In addition the rate of bladder dysfunction depends on the radicality of surgery.Nerve sparing readical hysterectomy that is currently being practised should reduce the bladder dysfunction.Currently controversy exists with regard to theduration of bladder drainage and choice of catheter used in bladder drainage.

Although survival outcomes of women with early stage cervical cancer after radical hysterectomy are excellent, surgery was frequently associated with post operative complications particularly bladder dysfunction that affects quality  of life.Also there is evidence that prolonged bladder  catheterisaton may have adverse effeccts such as delayed ambulation and urinary tract infections.

all patients undergoing radical hysterctomy at our center will be invited to participate in this study and will have an equal chance of early or late catheter removal.The early group will have catheter removed before discharge on 4th +/- 1 day and in the late group after discharge on 10th+/-1 day.Aftr catheter removal sample of urine will be sent for culture for all patients.If patient has a voiding problem the catheter will be put back.Any woman continuing to have bladder dysfunction will be taught clean intermittent self catheterisation and referred to urologist if problem persists after a month.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • All early stages (IA2, IB1,IIA1) cervical cancer undergoing radical hysterectomy.

排除标准

  • Non cervical cancer Previous pelvic irradiation Prior urinary dysfunction Bladder injury during surgery Other indications for prolonging bladder catheterisation.

结局指标

主要结局

Urinary infection rate

时间窗: after adequate sample collection

次要结局

  • Urinary retention rate (Recatheterisation rate)(Bladder dysfunction rate (CIC rate))

研究者

发起方
FLUID RESEARCH GRANT
申办方类型
Research institution and hospital

研究点 (1)

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