Conventional PCNL Versus Tubeless PCNL

Study Overview
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Brief Summary
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prospective randomized study measuring the safety and efficacy of tubeless PNL in patients at assiut university hospital comparing to the standard PNL

Detailed Description
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Percutaneous nephrolithotomy (PNL) is considered to be the procedure of choice for the treatment of upper urinary tract calculi. It was first introduced in 1976, and since that the operative technique and the endoscopic equipments underwent many modifications to increase the success rates and to decrease complications. Because of high success rate, low morbidity and complication rate, this minimally invasive modality has replaced the open surgical approach. the standard procedure is to place nephrostomy tubes within the tract of varying caliber and types. This was done to facilitate maximal collecting system drainage, to tamponade the access tract and also securing the access in case of 2nd look PNL was needed. multiple studies demonstrate significant morbidity associated with nephrostomy tube following PNL, mainly postoperative pain that requires significant narcotic and also long hospital stay. the idea of the tubeless PCNL was born, whereby a nephrostomy tube is not left in place following the percutaneous procedure, but rather renal drainage is established with an indwelling ureteral stent. Tubeless PNL has been challenged by certain problems as regard the selection of the patients. Another problem that is facing the tubeless PNL may be is the question regarding the access tract and how to deal with?. Finally, Percutaneous nephrolithotomy (PCNL) has become the standard treatment for kidney stones and/or upper ureter, but Whether nephrostomy tube placement is necessary after PCNL is still a matter of debate

Official Title
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Comparative Study Between Tubeless and Standard Percutaneous Nephrolithotomy. Randomized Controlled Trial (RCT)

Conditions
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Percutaneous Nephrolithotomy

Intervention / Treatment
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* Procedure: percutaneous nephrolithotripsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients above 18 years old 2. Patients with any stone burden and stone number requiring single procedure Exclusion Criteria: 1 - Patients aged below 18 years old. 2. Anatomical variation of the kidney in shape or position, e.g. horseshoe kidney or malrotation. 3. Complex or staghorn stones requiring staged procedure. Intra operative criteria: 4. Three or more access tracts. 5. Significant intraoperative bleeding. 6. Intraoperative pelvi calyceal system perforation. 7. Residual stones necessitate 2nd look PNL

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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
Interventional Model Description: group of patients will be submitted for conventional PCNL other group will be submitted to tubeless PCNL
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional<br>this arm will have both nephrostomy tube and ureteric catheter after completing the operation | Procedure: percutaneous nephrolithotripsy<br>* removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast<br>* Other names: PCNL;|
| Active Comparator: tubeless<br>the arm will have only ureteric catheter rafter completing the operation | Procedure: percutaneous nephrolithotripsy<br>* removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast<br>* Other names: PCNL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of days of hospital stay for both groups | comparison between number of days in hospital for both groups | 15 days | 
| dose of analgesia used to control pain after the procedure | comparison between the dose of analgesia needed for both groups in milligram | 5 days |