Multitract Percutaneous Nephrolithotomy(PCNL) in Large Renal Stones.

Study Overview
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Brief Summary
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Investigator aimed to analyze the clinical efficacy and safety of multiple tracts PCNL as one step therapy to treat the staghorn stones or multiple calyceal calculi which are inaccessible by single tract

Detailed Description
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Staghorn calculi are branched stones either partial or complete occupying the pelvis and one or more of the renal caliceal system that is detected by non contrast computrized tomography (NCCT) and plain on kidney, ureter, urinary bladder (KUB). An untreated staghorn calculus over time can damage the kidney and deteriorate its function and /or cause life threatening sepsis. Total stone clearance is an important goal to eradicate any infective focus, relieve obstruction and preserve the kidney function. Based on American Urological Association (AUA) guideline, PCNL is the most effective, safest and minimally invasive treatment option compared to open surgery

Official Title
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Multitract PCNL as One Step for Management of Large Renal Stones

Conditions
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Staghorn Calculi

Intervention / Treatment
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* Procedure: PCNL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients more than 18 years old. Patients with staghorn stone (partial, complete). Patients with multiple calyceal calculi which are inaccessible by single tract. Exclusion Criteria: Patients under 18 years old. Patients with renal anomalies. Patients with only function kidney. Patients with distal ureteric obstruction. Patients with radiolucent stone. Patients with febrile urinary tract infection. Patients with abnormal coagulopathy state. Patients refused to participate in this study. pregnancy. Musculoskeletal deformity.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Multitract PCNL patients<br>Assessment of the multitract PCNL procedure in removal of large renal stones using pneumatic or laser lithotripsy. | Procedure: PCNL<br>* Percutaneous nephrolithotomy ( Extraction of the renal stones using the nephroscope/ Ureteroscope )<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate | Assessment of the instant postoperative stone free rate and after one month from the procedure for all 40 participants using the postoperative non contrast computerized tomography (NCCT )and plain on kidney , ureter, urinary bladder (KUB ) | The participants will be followed for one month after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Measuring the postoperative complications rates, classification of the severity of the complications will assess the safety of the procedure. | From the start of the operation and till one month after the patient discharge. | 
| Operative time | Measurment of the time from start of the operation till fixation of nephrostomy tube | Average of three hours | 
| Postoperative pain | Measurment of the postoperative pain score using the Visual analogue scale(VAS) that is divided into mild(1-3), moderate(4-6) and sever(7-10) according to the severity of the pain. | Within 24 hours postoperative and till the patient discharge | 
| Hospital stay | Postoperative hospital stay of the participants till thier discharge | Average of six days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCNL