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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06062849
Enrollment
90
Registered
2023-10-02
Start date
2023-08-01
Completion date
2024-02-01
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Calculi, Postoperative Pain

Keywords

percutaneous nephrolithotomy, nephrostomy tube, double J stent

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.

Interventions

DEVICEnephrostomy tube

we will investigate if a nephrostomy tube really necessary after PNL operations

we will investigate if a JJ stent really necessary after PNL operations

PROCEDUREtotally tubless

we will not insert any device after the procedure and investigate if a nephrostomy tube or JJ stent really necessary after PNL operations

Sponsors

Bursa City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain6 monthsinvestigators 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 leakage6 monthsResearchers will investigate whether there is a difference in urine leakage between the three groups by measuring the number of pads changed daily.

Countries

Turkey (Türkiye)

Contacts

Primary ContactAbdullah Erdogan, MD
dr.abderd@hotmail.com+905362665256
Backup ContactSedat Oner, MD
sedatoner@yahoo.com+905056726545

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026