跳至主要内容
临床试验/NCT06722703
NCT06722703尚未招募不适用

ESWL Vs Flexible Uretroscopy in Management of Upper Ureteric Stones a Prospective Randomized Study

Assiut University0 个研究点目标入组 42 人开始时间: 2025年1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
尚未招募
入组人数
42
主要终点
The stone-free rate (SFR)

研究概览

简要总结

This comparison between ESWL and flexible ureteroscopy aims to explore the efficacy, safety, and outcomes of these treatments for upper ureteric stones under 15 mm, focusing on stone-free rates, procedural risks, recovery times, and recurrence rates. A thorough understanding of these techniques is essential for optimizing patient outcomes and personalizing treatment strategies.

study aim to evaluate the effectiveness, safety, and cost of SWL compared to flexible uretroscopy in management patients with upper ureteric stone less than 15 mm in size

详细描述

The management of upper ureteric stones, particularly those less than 15 mm in size, has seen significant advancements with the development of minimally invasive techniques. Urolithiasis is a common condition, and selecting the most appropriate treatment is crucial for effective stone clearance and minimizing complications. Two widely used approaches in treating upper ureteric stones are Extracorporeal Shock Wave Lithotripsy (ESWL) and Flexible Ureteroscopy (FURS).

ESWL, a non-invasive procedure, uses focused shock waves to fragment the stone into smaller pieces that can be passed naturally through the urinary tract. Its non-invasiveness makes it an attractive option for many patients; however, its success is influenced by factors such as stone composition, location, and patient anatomy. In contrast, Flexible Ureteroscopy (FURS) is a minimally invasive endoscopic technique where a flexible ureteroscope is passed through the urinary tract to directly visualize and fragment the stone using a laser (usually a Holmium: YAG laser). This method allows for a more targeted approach and is often used when ESWL is less effective or contraindicated.

ESWL and FURS have distinct advantages and limitations, and the choice between them depends on factors including stone size, density, location, and patient-specific considerations such as body habitus and anatomical variations.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients age>18 years old. Stone site: upper ureteric stone. Stone side: unilateral stones Stone size: stones diameter up to 1cm Stone number: single or multiple Radio-opaque stone

排除标准

  • •patients with solitary kidney or only function kidney renal impairment present of distal obstruction pregnancy, current breast feeding. Bleeding tendency or anticoagulation. ipsilateral ureterolithiasis, Acute or chronic nephritis, or Renal tuberculosis aneurysm of the aorta or renal artery. inability to position the patient on the SWL table (eg, due to severe skeletal deformity or morbid obesity).
  • •radiolucent stones that are not visible on ultrasound. severe metabolic disturbances (eg, cystinuria, primary hyperparathyroidism, or renal tubular acidosis)

研究组 & 干预措施

ESWL group

Experimental

The surgical technique of shock wave lithotripsy

干预措施: shock wave lithotripsy (Procedure)

FURS group

Experimental

Flexible ureteroscope lithotripsy

干预措施: Flexible ureteroscope lithotripsy (Procedure)

结局指标

主要结局

The stone-free rate (SFR)

时间窗: 1 month

The stone-free rate (SFR) is defined as no evidence of clinically significant stone fragments (≥ 4 mm in size) in combination with a plain X-ray of the urinary tract (KUB) and urinary ultrasound one month after SWL or F-URS

次要结局

未报告次要终点

研究者

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

Taha Abdulrahim Bassery Bakhit

resident doctor at urology department Faculty of Medicine, Assiut University

Assiut University

相似试验

ESWL Vs Flexible Uretroscopy in Management of Upper... | 临床试验