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临床试验/NCT06970587
NCT06970587已完成不适用

Percutaneous Versus Transurethral Cystolithotripsy For The Management Of Bladder Calculi In The Pre-school Boys: Prospective Randomized Study

South Valley University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Cystolithotripsy treatment

研究概览

简要总结

Bladder stones are an uncommon condition in children, accounting for only 5% of urolithiasis in developed countries, whereas in developing nations, a greater number of children are affected due to the high incidence of urinary tract infections and inadequate nutrition, primarily a diet lacking in protein and rich in carbohydrates

详细描述

Bladder stones are typically categorized as either primary or secondary. Primary vesical stones are those not linked with urinary tract disease, and are typically found in children who experience episodes of diarrhea, as well as metabolic disorders resulting from inadequate hydration and nutrition.

Secondary bladder stones are linked to various urinary tract issues, such as obstruction at the bladder outlet, persistent infections, the presence of foreign objects, bladder diverticula, and neurological bladder problems.

The incidence of bladder stones is ten times more common in male than in female children, with children aged 1-5 years being more frequently affected, and the peak incidence occurs at 3 years of age.

The traditional treatment for bladder stones in children typically involves open cystolithotomy. The traditional open surgery has several inherent drawbacks, including a lengthy hospital stay, an unsightly suprapubic scar, the need for prolonged catheterization, the necessity for analgesic treatment, and the risk of post-operative wound infection .

Several minimally invasive treatment methods have been outlined, including transurethral cystolithotripsy (TUCL) and percutaneous cystolithotripsy (PCCL), with open cystolithotomy typically reserved for larger stones. In infants and toddlers, transurethral management bypasses abdominal invasion and its associated risks, such as paralytic ileus and fluid leakage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •All male preschool-aged patients (ages 1 to 6 years) who had a single bladder calculus measuring ≤ 20 mm in its longest dimensions diagnosed by ultrasonography or KUB.

排除标准

  • •Patients with proven bladder dysfunction, such as neurogenic bladder, bladder outlet obstruction, upper urinary tract stones requiring simultaneous ureteroscopy or percutaneous nephrolithotripsy,
  • •previous suprapubic procedure,
  • •severe skeletal malformation that prevents lithotomy position,
  • •bleeding tendency,
  • •active urinary tract infection

研究组 & 干预措施

Group A

Active Comparator

About 75 children suffering from bladder stone with a single bladder calculus ≤ 20 mm and managed by percutaneous cystolithotripsy (PCCL)

干预措施: percutaneous cystolithotripsy (Procedure)

Group B

Active Comparator

About 75 children suffering from bladder stone with a single bladder calculus ≤ 20 mm and managed by transurethral cystolithotripsy (TUCL)

干预措施: percutaneous cystolithotripsy (Procedure)

结局指标

主要结局

Cystolithotripsy treatment

时间窗: 45 minutes after the procedure begin

Assessment of the Urinary Bladder condition of the patients after the Cystolithotripsy either successes or complications

次要结局

  • operative time(45 minutes after the procedure begin)
  • Hospital stay duration(24 hours after the Cystolithotripsy operation)

研究者

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

Ahmed Mahmoud Hasan

Assistant Professor at Urology Department, Faculty of Medicine

South Valley University

研究点 (1)

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