Prospective Assessment of Procedure-Related and Patient-Reported Outcomes After Retrograde Intrarenal Surgery (RIRS) for Renal Calculi Less Than 20 mm

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Assessment of Procedure-Related and Patient-Reported Outcomes After Retrograde Intrarenal Surgery (RIRS) for Renal Calculi Less Than 20 mm

Conditions
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Renal Stone

Intervention / Treatment
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* Procedure: Retrograde Intrarenal Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flexible ureteroscope<br> | Procedure: Retrograde Intrarenal Surgery<br> <br> * Other names: Flexible ureteroscope;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stone free rate (SFR) | stone free rate after the procedure | It will be assessed by non contrast computed tomography for the participants one month after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors of operative time of the procedure | Predictors of operative time of the procedure | Immediately after the procedure | 
| - Post-operative complications using modified Dindo-Clavian grading system | - Post-operative complications (Type/rate/predictors) 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. | - Intra-operative surgeon perspective about procedure outcome 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 | • Post-operative pain: Postoperative pain will be evaluated in all patients by using visual analogue scale (VAS). The impact of patient-related, stone-related and procedure-related factors. | within 3 months after the procedure | 
| Patient -reported outcomes about General impression on the procedure using Freiburg Index of patient Satisfaction (FIPS). | 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) | Procedure impact on improvement in patient-reported outcomes measurements information system (PROMIS): PROMIS is a National Institute of Health (NIH) validated system to assess patient quality of life. The PROMIS survey consists of 43 questions assessing the following categories: anxiety/fear, depression/ sadness, fatigue, pain interference, physical function, and sleep disturbance. | within 3 months after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal stone, Calculi, Retrograde Intrarenal Surgery, Flexible ureteroscope