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

NCT06062849 | Unknown

• 1 other identifier: 2019-KAEK-140 / 2023-12/2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Kidney Calculi; Postoperative Pain

Keywords

percutaneous nephrolithotomy; nephrostomy tube; double J stent

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

totally tubeless

ACTIVE COMPARATOR

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

Procedure: totally tubless

tubeless

ACTIVE COMPARATOR

only JJ stent

Device: double J stent

nephrostomy tube

EXPERIMENTAL

nephrostomy tube

Device: nephrostomy tube

Interventions

nephrostomy tube DEVICE

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

nephrostomy tube

double J stent DEVICE

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

tubeless

totally tubless PROCEDURE

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

Also known as: there is no device

totally tubeless

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years and above
• Larger than 2 cm kidney stones

You may not qualify if:

• Under 18 years of age
• Anatomical anomalies (horseshoe kidney, ectopic kidney, ureteropelvic junction stenosis, ureteral stenosis),
• Uncorrectable bleeding diathesis
• Bilateral kidney stones

Sponsors & Collaborators

• Bursa City Hospital: lead

Study Sites (1)

Bursa City Hospital

Bursa, 16110, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Kidney Calculi; Pain, Postoperative

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Sedat Oner, MD

  Bursa City Hospital

  STUDY DIRECTOR

Central Study Contacts

Abdullah Erdogan, MD

CONTACT

+905362665256; dr.abderd@hotmail.com

Sedat Oner, MD

CONTACT

+905056726545; sedatoner@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: October 2, 2023
• Study Start: August 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

TU (1)