Is it Really Necessary to Insert a Nephrostomy Tube or Double J Stent in Percutaneous Nephrolithotomy?

Study Overview
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Brief Summary
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In this study, investigators aimed to compare the postoperative pain status and comfort situations depending on instruments used in the percutaneous nephrolithotomy operation

Detailed Description
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A total of 90 patients aged 18 and over will undergo percutaneous nephrolithotomy (PNL) for kidney stones of 2 cm or more between 01/08/2023 and 01/02/2024 will be included in the study. Preoperative demographic data of the patients, body mass index (BMI), stone size and stone location, hemogram, biochemistry, coagulation parameters, urine analysis, and urine culture test results will be recorded. Radiological evaluation will be obtained according to computerized tomography (CT) data. While patients aged 18 years and above with kidney stones larger than 2 cm were included in the study, patients under 18 years of age, patients with anatomical anomalies (horseshoe kidney, ectopic kidney, ureteropelvic junction stenosis, ureteral stenosis), patients with uncorrectable bleeding diathesis, bilateral kidney stones will not be included in the study. Patients who do not have major complications (serious bleeding, renal pelvis perforation) after the PNL procedure and residual stones cannot be detected according to the scopic image obtained will be randomized and divided into three groups. Patients in the first group will not be fitted with a Double J (JJ) stent and/or nephrostomy (Completely Tubeless), patients in the second group will only be fitted with a JJ stent, and patients in the third group will only be fitted with a 14 French Malecot nephrostomy. The patients' pain scores, analgesic use, hemoglobin values, operation success, complications, and additional procedure requirements in the postoperative period will be compared.

Official Title
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Is it Really Necessary to Insert a Nephrostomy Tube or Double J Stent in Percutaneous Nephrolithotomy?

Conditions
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Kidney Calculi, Postoperative Pain

Intervention / Treatment
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* Device: nephrostomy tube
* Device: double J stent
* Procedure: totally tubless


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years and above Larger than 2 cm kidney stones Exclusion Criteria: Under 18 years of age Anatomical anomalies (horseshoe kidney, ectopic kidney, ureteropelvic junction stenosis, ureteral stenosis), Uncorrectable bleeding diathesis Bilateral kidney stones

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: totally tubeless<br>there is no nephrostomy tube or double J (JJ) stent | Procedure: totally tubless<br>* we will not insert any device after the procedure and investigate if a nephrostomy tube or JJ stent really necessary after PNL operations<br>* Other names: there is no device;|
| Active Comparator: tubeless<br>only JJ stent | Device: double J stent<br>* we will investigate if a JJ stent really necessary after PNL operations<br>|
| Experimental: nephrostomy tube<br>nephrostomy tube | Device: nephrostomy tube<br>* we will investigate if a nephrostomy tube really necessary after PNL operations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | investigators will compare postoperative pain status between the three groups with a Visual Analog Scale (VAS) questionnaire at 0, 1, 6, 12, and 24 hours postoperatively. Participants will rate their pain on a scale of 1 to 10 in ascending order. | 6 months | 
| postoperative urine leakage | Researchers will investigate whether there is a difference in urine leakage between the three groups by measuring the number of pads changed daily. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous nephrolithotomy, nephrostomy tube, double J stent