Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube?

Study Overview
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Brief Summary
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Regarding to the distribution of nephrostomy tube (NT) size usage by country. There was a clear distinction between countries that used solely the small bore (SB) NT (Chile and Australia) and those that used solely the large bore (LB) NT (Czech Republic and Japan). There is also a trend toward SB NT in North America ( 75% in USA and Canada) and toward LB NT in South America ( 80% in Argentina and Mexico). In Europe the trend is equal ( 50% in Germany, France, Greece and UK). Based on previous data and in view of conflicting data about postoperative complication including extravasation, bleeding and hemoglobin change and pain between previous studies, we will conduct this randomised trial comparing SB and LB NT following PNL. Our aim to evaluate the safety of small versus large bore NT reporting complications using the Clavien-Dindo system with categorisation of PNL-specific complications

Official Title
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Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube? Randomised Controlled Trial

Conditions
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Urolithiasis, Nephrolithotomy, Percutaneous Nephrolithotomy (PNL), Nephrostomy Tube (NT), Pain

Intervention / Treatment
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* Procedure: large-bore nephrostomy tube (LBNT)
* Procedure: small-bore nephrostomy tube (SBNT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Staghorn calculi Renal pelvis stones =>2 cm Lower pole stones= >1.5 cm upper ureteral calculi =>1.5 cm SWL-resistant stones Exclusion Criteria: Age <18 years or Pregnancy Tubeless PNL Need for 3 percutaneous tracts intraoperative Morbid obesity (BMI >40) Refuse to complete study requirements Tumour in the presumptive access tract area or Potential malignant kidney tumour

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: large-bore nephrostomy tube (LBNT)<br>large-bore 22 french nephrostomy tube (LBNT) | Procedure: large-bore nephrostomy tube (LBNT)<br>* large-bore 22 french nephrostomy tube (LBNT)<br>* Other names: LBNT;|
| Active Comparator: small-bore nephrostomy tube (SBNT)<br>small-bore 14 french nephrostomy tube (SBNT) | Procedure: small-bore nephrostomy tube (SBNT)<br>* small-bore 14 french nephrostomy tube (SBNT)<br>* Other names: SBNT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hemoglobin reduction difference between groups | measured in gram/liter | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain score | Assessed by Visual Analogue Scale (VAS) points from 0 to 10 | 8 months | 
| postoperative patient satisfaction | measured by The Freiburg Index of Patient Satisfaction (FIPS score) from 1 to 6 | 8 months | 
| overall postoperative complication | assesed by Clavien-Dindo system | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous nephrolithotomy (PNL), Nephrostomy tube (NT), Pain, Patient satisfaction