Diagnostic Accuracy of Ultrasound Versus Fluoroscopy for Detecting Residual Fragments During Retrograde Intrarenal Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy detecting residual fragments during retrograde intrarenal surgery
研究概览
简要总结
The purpose of this study is to assess the accuracy of ultrasound and traditional fluoroscopy to find the residual fragments before retrograde intrarenal surgery is complete. This would ultimately limit the need for radiation exposure and improve the quality of clinical care given to patients and healthcare teams.
详细描述
Ultrasound is currently gaining popularity as an alternative imaging modality for the diagnosis and treatment of urolithiasis. However, the benefit of ultrasound on the diagnostic accuracy of detecting residual fragments during retrograde intrarenal surgery (RIRS) has never been evaluated in a randomized study. Its use would reduce radiation exposure for patients and care team members as well as improve stone free clearance rates for surgery. Therefore, The investigators plan to conduct a randomized trial to assess the diagnostic accuracy of ultrasound and fluoroscopy in conjunction with endoscopic examination for detecting residual stone fragments during retrograde intrarenal surgery. After admission, approximately 172 subjects will be randomized in a 1:1 ratio to receive ultrasound or fluoroscopy before completing RIRS. Subsequently, four weeks after the operation, the investigators will compare with routine low-dose non-contrast computed tomography as a gold standard for detecting residual fragments. If ultrasound is more accurate than fluoroscopy in detecting residual fragments, the investigators will encourage this approach as it can reduce radiation exposure for patients and healthcare professionals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Patients over the age of
- •Consecutive patients with a diagnosis of renal stone or ureteral stone with a plan to undergoing RIRS for stone removal.
排除标准
- •Patients who decline informed consent.
- •Pregnancy
- •Kidney transplantation
- •Ectopic kidney
- •Patients undergoing concurrent bilateral stone removal surgery.
- •Patients whose pain cannot be controlled when presenting at the Emergency Department.
结局指标
主要结局
Diagnostic accuracy detecting residual fragments during retrograde intrarenal surgery
时间窗: 4 weeks
The diagnostic accuracy of ultrasound and fluoroscopy will be measured in conjunction with endoscopic examination for detecting residual fragments during retrograde intrarenal surgery for renal stones treatment by the same endourologist to determine the size of the largest residual fragment, categorizing them as stone free, ≤ 2 mm, or \>2 mm, and compared with routine low-dose non-contrast computed tomography by a radiologist blinded to surgery and intraoperative imaging, categorizing them as stone free, ≤ 2 mm, or \>2 mm. The results will be compared for accuracy.
次要结局
- Specificity detecting residual fragments during retrograde intrarenal surgery(4 weeks)
- Operative time in minutes(Surgical duration, up to 4 hours)
- Sensitivity detecting residual fragments during retrograde intrarenal surgery(4 weeks)
- Positive predictive value detecting residual fragments during retrograde intrarenal surgery(4 weeks)
- Negative predictive value detecting residual fragments during retrograde intrarenal surgery(4 weeks)
- Surgical complications into grade I to V on the modified Clavien-Dindo classification from operation, up to 4 weeks.(From operation, up to 4 weeks)