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

Bursa City Hospital

Status: Enrolling

Conditions: Postoperative Pain; Kidney Calculi

Treatments: Procedure: totally tubless; Device: double J stent; Device: nephrostomy tube

Study type: Interventional

Funder types: Other

Identifiers

NCT06062849

2019-KAEK-140 / 2023-12/2

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

totally tubeless

Active Comparator group

Description:

there is no nephrostomy tube or double J (JJ) stent

Treatment:

Procedure: totally tubless

tubeless

Active Comparator group

Description:

only JJ stent

Treatment:

Device: double J stent

nephrostomy tube

Experimental group

Description:

nephrostomy tube

Treatment:

Device: nephrostomy tube