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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flexible ureteroscope | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retrograde Intrarenal Surgery | Procedure |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Ability to give informed consent.
Stone criteria:
Kidney criteria:
Patients criteria:
Exclusion Criteria:
Inability to give informed consent.
Stone criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amr A Elsawy, MD | Urology and Nephrology Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology and Nephrology Center | Al Mansurah | DK | 35516 | Egypt | ||
| Amr A Elsawy |
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- 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 |
| Al Manşūrah |
| 35516 |
| Egypt |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D002137 | Calculi |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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