The Use of Direct Puncture Technique With Mini-PCNL

Study Overview
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Brief Summary
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A single-center randomized study to evaluate the safety and effectiveness of direct puncture of the caliceal system in mini-percutaneous nephrolithotripsy. 60 patients Inclusion criteria: all patients aged 18 to 70 years who are planning mini-PCNL, ready to consent to the study ASA scale 1-3 Solitary stone up to 2.5 cm Single access to the caliceal system Exclusion criteria: Active infectious process Coagulopathies Abnormalities of the urinary system

Detailed Description
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All patients will be randomized into 2 groups: Direct puncture - patients who underwent directive puncture under ultrasound or Rg control. The number of patients is 30 people. Non-direct puncture - patients who underwent a PCS puncture with retrograde contrast. The number of patients is 30 people. Patients will be assigned a randomization number that matches their treatment. Block randomization using 10 blocks will be performed by a central randomization organization (www.randomize.net) using a computerized algorithm. Primary assessed indicators: Gender Age Body mass index Localization of the stone (side, pelvis, upper anterior cup, upper posterior cup, middle anterior cup, middle posterior cup, lower anterior cup, lower posterior cup) Density of the stone The presence of hydronephrosis Indicators assessed during the operation - will be assessed by the physician-researcher: Installation of the ureteral catheter Duration of puncture Puncture method (ultrasound, X-ray) The success of the insertion of a flexible guidewire into the calyceal system Problems during dilation of the puncture course Visualization (Excellent, Moderate, Poor) Type of drainage (stent, nephrostomic tube) at the end of the operation Using the Visual Analogue Pain Scale (VAS), pain assessment is planned at 2 hours, 6 hours, 12 hours and 24 hours after surgery. In the postoperative period, the patient independently controls the intake of analgesics from the NSAID group (ketorolac 100 mg) (Patient-controlled analgesia). If the patient requires analgesics, the time of taking the drug will be recorded (pain relief on demand). Secondary Assessment: Postoperative Assessment Complications (Clavien) Hemoglobin level 24 hours after surgery Creatinine level 24 hours after surgery Assessment of Stone-Free status after surgery by performing multislice computed tomography of the kidneys and urinary tract without intravenous contrast

Official Title
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Single-center Randomized Study to Evaluate the Safety and Effectiveness of Direct Puncture of the Caliceal System in Minipercutaneous Nephrolithotripsy (Mini-PCNL)

Conditions
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Urolithiasis

Intervention / Treatment
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* Procedure: Puncture of the caliceal system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 70 years who are scheduled for mini-PCNL, ready to consent to the study ASA scale 1-3 Solitary kidney stone up to 2.5 cm One access to the caliceal system Exclusion Criteria: Active infectious process Coagulopathies Abnormalities of the urinary system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct puncture<br>Direct puncture of the caliceal system performed under ultrasound or Xray control | Procedure: Puncture of the caliceal system<br>* Puncture of the caliceal system under ultrasound/Xray control<br>|
| Active Comparator: Non-direct puncture<br>Puncture of the caliceal system performed under ultrasound or Xray control and retrograde contrast | Procedure: Puncture of the caliceal system<br>* Puncture of the caliceal system under ultrasound/Xray control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Puncture duration | Measurement of puncture duration (in seconds) | during the operation (mini-PCNL) | 
| Number of patients with successful direct puncture | Evaluation of efficacy | during the operation (mini-PCNL) | 
| Purity of a visual intraoperative field | Excellent, Moderate, Poor visualization | during the operation (mini-PCNL) | 
| Body pain | Using the Visual Analogue Pain Scale (VAS), pain assessment is planned at 2 hours, 6 hours, 12 hours and 24 hours after surgery | 24 hours after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urolithiasis, PCNL, direct puncture