NCT06062849

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Bursa City Hospital · Other Government
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Kidney Calculi
• Postoperative Pain

Interventions

Type	Name	Description
DEVICE	nephrostomy tube	we will investigate if a nephrostomy tube really necessary after PNL operations
DEVICE	double J stent	we will investigate if a JJ stent really necessary after PNL operations
PROCEDURE	totally tubless	we will not insert any device after the procedure and investigate if a nephrostomy tube or JJ stent really necessary after PNL operations

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2023-10-02
• Last updated: 2023-11-07

Locations

1 site across 1 country: Turkey (Türkiye)