Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones.

Study Overview
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Brief Summary
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The EUA Urolithiasis Guidelines Panel meta-analysis suggest that mPNL is at least as efficacious and safe as sPNL for the removal of renal calculi. However, the quality of the evidence was poor, drawn mainly from small studies, the majority of which were single-arm case series, and only one of which was RCT. The risks of bias and confounding were high, highlighting the need for more reliable data from RCTs. So, the Panel recommended for more clinical research . The aim of this study is to compare between PNL and mPNL through a randomized controlled trial.

Official Title
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Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones. A Randomized Controlled Trial

Conditions
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Nephrolithiasis, Urolithiasis, Stone;Renal, PNL, PCNL, NEPHROLITHOTOMY, MINIPERC

Intervention / Treatment
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* Procedure: MINI-PERCUTANEOUS NEPHROLITHOTOMY
* Procedure: STANDARD PERCUTANEOUS NEPHROLITHOTOMY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient 18 years or older. ASA I or II Renal stones ≥ 2 cm Lower calyceal stone ≥ 1 cm Failure of other modalities of treatment as ESWL and RIRS. Exclusion Criteria: S.creatinine > 2mg/dl. Patients with active UTI. Patients on anticoagulant. Age <18 years. Ureteral obstruction preventing the insertion of a ureteral stent.

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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No

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: MINI-PERCUTANEOUS NEPHROLITHOTOMY<br>MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION | Procedure: MINI-PERCUTANEOUS NEPHROLITHOTOMY<br>* MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION<br>* Other names: MINI-PERC;|
| Active Comparator: STANDARD PERCUTANEOUS NEPHROLITHOTOMY<br>PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION | Procedure: STANDARD PERCUTANEOUS NEPHROLITHOTOMY<br>* PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION<br>* Other names: STANDARD PNL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of stone free rate (SFR) | defined as less than 4mm by non contrast computed tomography | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of haemoglobin loss | measured by haemoglobin change pre and postoperative (measured by grams/ deciliter) | 2 years | 
| assessment of pain | measured by visual analogue scale | 2 years | 
| assessment of renal function | measured by serum creatinine measured by Milligram/ deciliter | 2 years | 
| assessment of patient satisfaction | measured by freiburg index of patient satisfaction | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urolithiasis, stone, renal, nephrolithiasis, PNL, PCNL, NEPHROLITHOTOMY, MINIPERC, MINI-PERC, BLOOD LOSS, NEPHROSTOMY SIZE