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临床试验/NCT02434068
NCT02434068Unknown不适用

Assessment of Flexible Ureteroscopy Residual Fragments

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
115
试验地点
1
主要终点
residual calculi > 2mm by CT

研究概览

简要总结

Residual fragments of urinary calculi after flexible ureteroscopy (URF) can cause symptoms and additional surgeries. The assessment of residual fragments by imaging is not standardized. Computed tomography (CT) is the best way for evaluation of urinary stones, however, ionizing radiation from CT is deleterious. The aim of this study is to define which patients may avoid CT for evaluation of residual fragments after URF. 115 patients with > 18 years old undergoing URF for kidney stone < 20 mm or < 15 mm in the lower calyx diagnosed by CT will be studied. The clinical evaluation of patients will be held by the same urologist in pre-operative consultation, 7 days after the procedure, 30 days after the procedure and 100 days after the procedure. The assessment of residual fragments will be made through TC, ultrasound and Kidney-bladder-ureter KUB 90 days after the procedure. The image methods for residual fragments assessment will be compared by Cochran Test and prediction of parameters to avoid CT will be made by multiple logistic regression, using IPSS 16.0, with significant level of 5%.

详细描述

Flexible ureteroscopy (URF) is being widely used for the treatment of kidney stones up to 20 mm. The assessment of residual fragments must be done because they could cause pain and additional surgical interventions. However, nor the timing or modality of image study for this assessment is standardized yet.

Computed Tomography (CT) has become the standard for diagnosing urinary stones. Stone-former patients are submitted to many CT studies during life due to stone-related events. However, the cumulative exposure to the ionizing radiation of CT may induce tumors. Therefore, efforts to reduce radiation exposure are recommended such as better selection of the timing to submit the patient to CT, low radiation dose protocols and restriction of body region to be examined.

Up to 38% of the patients have residual fragments more than 2 mm assessed by CT after URF. The investigators goal is to predict witch patients should be submitted to CT for the assessment of residual fragments after URF and to evaluate the clinical significance of residual fragments and URF complications.

Method

115 consecutive symptomatic adult (>18 years-old) patients diagnosed by CT with kidney stone more than 5 mm and less than 20 mm or less than 15 mm in inferior calyx are going to be submitted to URF. Residual fragments are going to be assessed by CT, ultrasound and plain radiography during post-operative period. The study protocol is approved by our hospital's ethics committee, and written informed consent is going to be obtained from all patients according to the Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Kidney calculi > 5 mm and < 20 mm or < 15 mm in lower kidney calyx

排除标准

  • Patients with kidney malformations, ureteral stenosis, previous ipsilateral kidney surgery, hydronephrosis, indwelling double J stent and contraindications for URF are going to be excluded.

结局指标

主要结局

residual calculi > 2mm by CT

时间窗: 90 days

次要结局

  • complications by CT(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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