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临床试验/NCT03855787
NCT03855787已完成不适用

Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial

Vanderbilt University Medical Center14 个研究点 分布在 2 个国家目标入组 103 人开始时间: 2019年11月11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
103
试验地点
14
主要终点
Total number of complications

研究概览

简要总结

The rationale for this study is to determine if there is a difference in complications among patients undergoing ureteroscopy for renal stones who receive a stent compared to not receiving a stent postoperatively.

详细描述

Kidney stones affect 9% individuals within the United States, and the prevalence is increasing. Over the last few decades, ureteroscopy has become the most commonly performed stone procedure. However the complication rate after ureteroscopy is not insignificant. Reducing morbidity after ureteroscopy would improve patient outcomes and reduce health care utilization.

A major contributor to patient morbidity after ureteroscopy is the ureteral stent, which is placed at the time of surgery and left in place 1-2 weeks after surgery. The rationale for utilizing stents is to prevent urinary obstruction from edema or stone fragments. On the other hand, stents cause hematuria, pain, and lower urinary tract symptoms. Additionally, stent-related symptoms are often misdiagnosed as urinary tract infections leading to unnecessary antibiotic use.

The clinical utility of ureteral stents after ureteroscopy has not been well studied, specifically a stone located in the kidney. Prior studies on stent-less ureteroscopic procedures have focused on treatment of ureteral stones and not stones located in the kidney, have had restrictive inclusion and exclusion criteria, are primarily from single center institutions, and most being performed ~15 years ago. Surgical techniques and device innovations have changed the procedure since that time. To date, there have been only 2 studies that included stone located in the kidney showing no difference in unplanned hospital revisits, however both combined analyses with ureteral stones and selection bias was an issue for both studies. In addition, there is a lack of studies assessing opiate use, impact of quality of life with stent placement, and loss of work related to stent placement

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

入选标准

  • nonobstructing renal stone 1.5cm total stone diameter (if multiple stones, then sum of maximum diameters) or less undergoing ureteroscopy

排除标准

  • age < 18 years
  • pregnancy status
  • ureteral stone
  • preoperative hydronephrosis
  • indwelling nephrostomy tube
  • planning bilateral ureteroscopy or subsequent staged ureteroscopy
  • solitary kidney or eGFR <60 mL/min (CKD stage 3 or greater)
  • variant anatomy including horseshoe kidney, pelvic kidney, prior urinary tract reconstruction

研究组 & 干预措施

Ureteral stent group

Active Comparator

A ureteral stent will be placed after ureteroscopy.

干预措施: Ureteroscopy (Procedure)

No ureteral stent group

Active Comparator

A ureteral stent will not be placed after ureteroscopy.

干预措施: Ureteroscopy (Procedure)

结局指标

主要结局

Total number of complications

时间窗: 30 days after ureteroscopy

Total number of complications - Defined as ER visits related to procedure, unanticipated provider visit, and hospitalization

次要结局

  • % return to work(5-10 days after ureteroscopy)
  • WISQOL (Wisconsin Stone Quality of Life Questionnaire)(baseline to 5-10 days after ureteroscopy)
  • Cumulative opiate morphine equivalent dosing (MED)(baseline to 5-10 days after ureteroscopy)
  • PROMIS (Patient-Reported Outcomes Measurement Information System) form 6a(baseline to 5-10 days after ureteroscopy)
  • Number of participants with abnormal imaging findings(4-8 weeks after ureteroscopy)
  • Number of participants with symptomatic urinary tract infection (UTI)(Baseline 5-10 days after ureteroscopy)

研究者

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

Ryan Hsi

Associate Professor

Vanderbilt University Medical Center

研究点 (14)

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