跳至主要内容
临床试验/NCT03567421
NCT03567421已完成不适用

Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes

Société Internationale d'Urologie50 个研究点 分布在 15 个国家目标入组 2,348 人开始时间: 2018年6月7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
2,348
试验地点
50
主要终点
Incidence of patients receiving an internal drain following treatment for urinary stones by ureteroscopy

研究概览

简要总结

Background: The exit strategy after ureteroscopy for stone treatment remains a topic for discussion. Current EAU guidelines on urolithiasis state that postoperative stenting is indicated in patients at increased risk of postoperative complications. Stenting is not considered necessary in all other cases, and after uncomplicated procedures.

Objective: To analyse the postoperative ureteral stenting strategy in clinical practice looking at the indication, type of stents used and the duration of stenting after ureteroscopy for stone treatment. Furthermore, the investigators will examine in what setting the stents are being removed postoperatively.

Study design: This study is a prospective, observational, international, multicentre registry study executed by uCARE.

Study population: All patients >18 years with a ureter or renal stone who are planned for ureteroscopic treatment by semi-rigid and/or flexible ureteroscopy are eligible for this study.

详细描述

BACKGROUND AND RATIONALE

The majority of patients with stones receive an indication for its active removal by ureteroscopy. In the last two decades, endourological treatment techniques have evolved with several technological advances through miniaturisation of ureteroscopes, digital improvements, and optical imaging enhancement techniques leading to a better image quality, and the development of different disposables such as single-use digital ureteroscopes. This advancement has led to an increased number of indications for ureteroscopic treatment. Aside from this, there are no specific contraindications for ureteroscopic treatment, apart from general problems such as being unfit for anaesthesia or the presence of urinary tract infections, according to the EAU guidelines.

The indications for active stone removal of ureteral stones include persistent pain or obstruction, renal insufficiency, and in cases when spontaneous passage is less likely. The indications for active removal of renal stones include stone growth, stone formation in patients who are at high risk for stone formation, symptomatic patients, infection, obstruction, stones larger than 15 mm and the comorbidity profile, social situation and preference of the patient.

The procedure can be performed using semi-rigid instruments, mainly for ureter stones, and/or by flexible ureteroscopes, for complete inspection and treatment of the upper tract.

The exit strategy after stone treatment varies depending on patient characteristics and comorbidity, residual stone load, per-operative details and complications, and surgeons' preference. Stent placement is recommended by the EAU guidelines in case of increased postoperative complications; in cases of residual fragments, bleeding, perforation, pregnancy or urinary tract infections; as well as in all doubtful cases to avoid stressful emergencies.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient >18 years old
  • Patient is a candidate for ureteroscopic treatment of a ureter or renal stone by semi-rigid and/or flexible ureteroscopy

排除标准

  • Patient <18 years old

结局指标

主要结局

Incidence of patients receiving an internal drain following treatment for urinary stones by ureteroscopy

时间窗: 6 months

This number will be reported as a % of the total patients enrolled.

次要结局

  • Duration of the actual internal drain indwelling time [days](6 months)
  • % of patients who required anaesthesia for stent removal [Yes/No](6 months)
  • Incidence of use of flexible instruments for stent removal following ureteroscopy.(6 months)
  • Number of patients requiring secondary interventions [N](6 months)
  • Number of patients requiring pain medication at discharge [N](6 months)
  • Duration of the internal drain indwelling time as indicated by the surgeon [days](6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (50)

Loading locations...

相似试验