Comparison of Surgical Outcomes Between MPCNL and RIRS

Study Overview
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Brief Summary
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The objective of this research is to investigate the surgical outcomes of minimally invasive percutaneous nephrolithotomy(MPCNL) and retrograde intrarenal surgery (RIRS)for patients with renal stone larger than 1cm.

Detailed Description
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It is pointed out that there is the disadvantage of conventional PCNL technique which showed dramatic decrease in Hb and renal damage even though it has some advantages of a short operation time and a high stone-free rate. MPCNL and RIRS has recently been considered as very efficacious methods.

Official Title
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Comparison of Surgical Outcomes in the Treatment of Renal Stones Larger Than 1 Centimeters Between MPCNL and RIRS: a Single-center, Randomized, Prospective Study

Conditions
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Renal Stone

Intervention / Treatment
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* Device: RIRS
* Device: MPCNL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The person who has been diagnosed with renal stone larger than 1cm renal and who has been supposed to undergo MPCNL or RIRS. The person who signed up for participation and agree with intention of clinical test. Exclusion Criteria: The patient whose medical record has been omitted from database. The patient who has an anatomical abnormality of urinary tract and/or metabolic illness The patient who do not agree with the intention of the clinical study.

Ages Eligible for Study
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Minimum Age: 20 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RIRS (retrograde intrarenal surgery)<br>Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract | Device: RIRS<br>* RIRS arm Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract<br>* Other names: retrograde intrerenal surgery;|
| Experimental: MPCNL (mini-perc)<br>A new technique that reduced the size of percutaneous tract to make renal stone into small pieces. Patients will be randomized and assigned to each group at the ratio 1:1 | Device: MPCNL<br>* MPCNL arm A new technique that reduced the size of percutaneous tract to make renal stone into small pieces.<br>* Other names: mini-perc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stone-free rate | We will check the non-contrast CT scan at postoperative 1month when the patient visit the outpatient department. If the patient does not have any residual stone fragment, it will be reported to 'success.' Otherwise, we will measure the size of each stone of residual fragments. | postoperative 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | Visual analogue scale will be measured: 0 (no pain) -> 10 (the most worst pain ever experienced) | postoperative 1 day | 
| hemoglobin drop | preoperative Hb level - Hb level of immediate postoperative 1 day | postoperative 1 day | 
| occurrence of complications | occurrence of stricture in non-contrast CT scan history taking of hematuria or fever | postoperative 1 day, and the postop 1month at OPD | 
| hospital stay | calculation of days of hospital stay | postoperative 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous nephrolithotomy, renal calculi, ureteroscopy