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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062849
• Other study ID #: 2019-KAEK-140 / 2023-12/2
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: November 2023
• Source: Bursa City Hospital
• Contact: Abdullah Erdogan, MD
• Phone: +905362665256
• Email: dr.abderd[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Bursa City Hospital	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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