Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Urolithiasis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

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. P...

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

Tracking Information

NCT #
NCT04610840
Collaborators
Not Provided
Investigators
Not Provided