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

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

Study Overview

• Status: Recruiting
• Conditions: Kidney Calculi; Postoperative Pain
• Intervention / Treatment: Procedure: totally tubless; Device: double J stent; Device: nephrostomy tube

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdullah Erdogan, MD; Phone Number: +905362665256; Email: dr.abderd@hotmail.com
• Study Contact Backup: Name: Sedat Oner, MD; Phone Number: +905056726545; Email: sedatoner@yahoo.com

Study Locations

• Turkey
  • Bursa, Turkey, 16110
    • Recruiting
    • Bursa City Hospital
    • Contact: Abdullah Erdogan, MD; Phone Number: +905362665256

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nephrostomy tube	Device: nephrostomy tube; we will investigate if a nephrostomy tube really necessary after PNL operations
Active Comparator: totally tubeless; there is no nephrostomy tube or double J (JJ) stent	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; Other Names: there is no device
Active Comparator: tubeless; only JJ stent	Device: double J stent; we will investigate if a JJ stent really necessary after PNL operations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Bursa City Hospital
• Investigators: Study Director: Sedat Oner, MD, Bursa City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 4, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: percutaneous nephrolithotomy; nephrostomy tube; double J stent
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: 2019-KAEK-140 / 2023-12/2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No