NCT03719456已完成不适用
Prospective Assessment of Procedure-Related and Patient-Reported Outcomes After Retrograde Intrarenal Surgery (RIRS) for Renal Calculi Less Than 20 mm
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
- 340
- 试验地点
- 2
- 主要终点
- stone free rate (SFR)
研究概览
简要总结
The investigators aim at this study to prospectively assess procedure-related outcomes after RIRS for renal calculi less than 20 mm, including stone free rate (SFR), predictors of successful outcome, complications types/rate, readmission rate and the need of auxiliary procedures. In addition, patient-reported outcomes after this modality of intervention are going to be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Ability to give informed consent.
- •Stone criteria:
- •Less than 20 mm.
- •Infectious stone.
- •Growing stone on follow-up.
- •Kidney criteria:
- •Obstructing stone causing hydronephrosis.
- •Solitary kidney or bilateral renal stones.
- •Patients criteria:
- •Age ≥18 years.
- •Symptomatic stone causing pain or hematuria.
- •Patient comorbidity omitting other modalities as bleeding diathesis or skeletal deformities.
- •Patient preference or patients' social situation concerning profession or amount of travel
排除标准
- •Inability to give informed consent.
- •Stone criteria:
- •More than 20 mm.
- •Peripheral calyceal asymptomatic stone static in size on follow-up.
- •Unsuitable/failure of initial treatment modalities (oral dissolution therapy-SWL) for stones less than 20 mm.
研究组 & 干预措施
Flexible ureteroscope
Experimental
干预措施: Retrograde Intrarenal Surgery (Procedure)
结局指标
主要结局
stone free rate (SFR)
时间窗: It will be assessed by non contrast computed tomography for the participants one month after the procedure
stone free rate after the procedure
次要结局
- Predictors of operative time of the procedure(Immediately after the procedure)
- - Post-operative complications using modified Dindo-Clavian grading system(within 30 days after the procedure)
- Intra-operative clinical judgment of the surgeon on stone free status using flouroscopy and visual scanning of pelvicalyceal system and its relation to post-operative NCCT.(Post operative day 1 after the procedure)
- - Patient -reported outcomes about post operative pain using visual analogue scale(within 3 months after the procedure)
- Patient -reported outcomes about General impression on the procedure using Freiburg Index of patient Satisfaction (FIPS).(within 3 months after the procedure)
- Assessment of patient-reported outcomes using patient-reported outcomes measurements information system (PROMIS)(within 3 months after the procedure)
研究者
Amr Abdel-Lateif El-Sawy
Principal Investigator
Mansoura University
研究点 (2)
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