Renal Stone
Conditions
Keywords
Renal stone, Calculi, Retrograde Intrarenal Surgery, Flexible ureteroscope
Brief summary
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.
Interventions
PROCEDURERetrograde Intrarenal Surgery
Sponsors
Mansoura University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Ability to give informed consent. 2. Stone criteria: * Less than 20 mm. * Infectious stone. * Growing stone on follow-up. 3. Kidney criteria: * Obstructing stone causing hydronephrosis. * Solitary kidney or bilateral renal stones. 4. 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
1. Inability to give informed consent. 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| stone free rate (SFR) | It will be assessed by non contrast computed tomography for the participants one month after the procedure | stone free rate after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| - Post-operative complications using modified Dindo-Clavian grading system | within 30 days after the procedure | \- Post-operative complications (Type/rate/predictors) using modified Dindo-Clavian grading system |
| 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 | \- Intra-operative surgeon perspective about procedure outcome and its relation to post-operative NCCT. |
| Predictors of operative time of the procedure | Immediately after the procedure | Predictors of operative time of the procedure |
| Patient -reported outcomes about General impression on the procedure using Freiburg Index of patient Satisfaction (FIPS). | within 3 months after the procedure | Patient -reported outcomes about General impression on the procedure using Freiburg Index of patient Satisfaction (FIPS). |
| Assessment of patient-reported outcomes using patient-reported outcomes measurements information system (PROMIS) | within 3 months after the procedure | 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. |
| - Patient -reported outcomes about post operative pain using visual analogue scale | within 3 months after the procedure | • 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. |
Countries
Egypt
Outcome results
None listed