Management of Lower Pole Renal Hard Stones ≤2 cm

Study Overview
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Brief Summary
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The study has been conducted in Urology department at Kafrelsheikh University Hospital between March 2022 to March 2023. informed consent was taken from eligible patients and were randomized into three groups, Group A :Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue) while, Group B : extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany) .Group C : Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.

Official Title
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Flexible Ureteroscopy , Extracorporeal Shock Wave Lithotripsy and Mini Percutaneous Nephrolithotomy for Management of Lower Pole Renal Hard Stones ≤2 cm: Prospective Comparative Study

Conditions
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Renal Stones

Intervention / Treatment
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* Procedure: lithotripsy using Flexible ureteroscope
* Procedure: extracorporeal shock wave lithotripsy (ESWL)
* Procedure: holmium laser lithotripsy using Karl® Storz MIP set


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient older than 18 years. single renal stone. medium sized Stone up to 2.0 cm . Do novo Stone in lower calyceal stone Hard stone Exclusion Criteria: • multiple renal stones stone size > 2 cm age group < 18 solitary kidney Patients with BMI > 40 kg/m2 bleeding disorders anatomical renal abnormalities Obstruction distal to the stone. Musculoskeletal deformities

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A :Flexible ureteroscope group<br>Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue) | Procedure: lithotripsy using Flexible ureteroscope<br>* using Flexible ureteroscope and holmium laser lithotripsy to get high stone clearance rate<br>|
| Active Comparator: Group B : extracorporeal shock wave lithotripsy (ESWL) group<br>extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany) | Procedure: extracorporeal shock wave lithotripsy (ESWL)<br>* using extracorporeal shock wave lithotripsy (ESWL) to get high stone clearance rate<br>|
| Active Comparator: Group C : Mini perc group<br>Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set. | Procedure: holmium laser lithotripsy using Karl® Storz MIP set<br>* using holmium laser lithotripsy using Karl® Storz MIP set to get high stone clearance rate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stone free rate | no stone residual fragments or asymptomatic insignificant residual fragments less than or equal to 4 mm during patients follow up two weeks. | after two weeks from primary procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess operative time. | assess operative time.in minutes | during the procedure | 
| visual analog scale | Patient self dependent to assess degree of own pain, consists of a 10cm line, with two end points representing 0 minimum score('no pain') and 10 maximum score('pain as bad as it could possibly be').higher scores mean a worse outcome. | immediately after the surgery | 
| Radiation time | Time of patient exposure for radiation in minutes | during the procedure | 
| Post operative complication | Complication may occur post operative complication like fever, sever pain | Up to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hard stones