Bilateral Synchronous Simultaneous Stone Surgery

Study Overview
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Brief Summary
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Advancements in technology and endourological armamentarium provides multiple surgical options for complicated stone patients. To avoid multiple operations and shorten the total operation durations, bilateral synchronous simultaneous stone surgery (BSSSS) has been popularized in recent years. Our aim is to evaluate the preliminary outcomes of BSSSS in patients undergoing supine percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS).

Official Title
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Evaluation of Efficacy and Safety Profile of Bilateral Synchronous Simultaneous Stone Surgery for Kidney Stones

Conditions
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Kidney Calculi, Nephrolithotomy, Percutaneous, Ureteroscopy

Intervention / Treatment
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* Procedure: Bilateral synchronous simultaneous stone surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients scheduled for kidney stone surgery according to European Association Urology, Urolithiasis guidelines patients with bilateral kidney stones Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: Bilateral synchronous simultaneous stone surgery<br>Patients who will be operated for kidney stones at both their kidneys in a single surgery session will be included in the study. Patients will undergo percutaneous nephrolithotomy for one side and flexible ureteroscopy for the other side. | Procedure: Bilateral synchronous simultaneous stone surgery<br>* Patients undergoing Bilateral synchronous simultaneous stone surgery (one kidney undergoing percutaneous nephrolithotomy, other kidney undergoing ureteroscopy at the same time in a single patient)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate | stone free status is decided according to both the immediate evaluation of the endoscopic view at the end of the operation and the post operative imaging with kidney, ureter, bladder X-ray at the 24th hour of the surgery | at the 24th hour of the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Complications are assessed according to Clavien Dindo classification | at the 1st week of surgery | 
| Post operative urinary diversion | evaluation of patients whether they have a nephrostomy or a ureteral stent at the end of the operation | at the 24th hour of surgery | 
| Radiation exposure | The cumulative fluoroscopy dose that was emitted during surgery | At 1st hour of surgery | 
| Hemoglobin level change | The amount of hemoglobin drop during and after surgery | from baseline to 24th hour of surgery | 
| Hospital stay | The amount of days that the patient stayed at the hospital | will be assessed through completion of study, an average of 1 year. | 
| Residual stone | The diameter of the stones that couldn't be retracted | at the 24th hour of surgery |