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

Not Applicable

Recruiting

• Conditions: Kidney Calculi; Postoperative Pain
• Interventions: Device: double J stent; Procedure: totally tubless; Device: nephrostomy tube

• Registration Number: NCT06062849
• Lead Sponsor: Bursa City Hospital

Brief 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.

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-04
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tubeless	double J stent	only JJ stent
totally tubeless	totally tubless	there is no nephrostomy tube or double J (JJ) stent
nephrostomy tube	nephrostomy tube	nephrostomy tube

Primary Outcome Measures

Name	Time	Method
postoperative pain	6 months	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.
postoperative urine leakage	6 months	Researchers will investigate whether there is a difference in urine leakage between the three groups by measuring the number of pads changed daily.

Trial Locations

Locations (1)

Bursa City Hospital; 🇹🇷 Bursa, Turkey