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

Sponsor
Bursa City Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06062849
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
6
Anticipated Duration (Months)
14.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: nephrostomy tube
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Is it Really Necessary to Insert a Nephrostomy Tube or Double J Stent in Percutaneous Nephrolithotomy?
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: totally tubeless

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

Device: nephrostomy tube
we will investigate if a nephrostomy tube or JJ stent really necessary after PNL operations
Other Names:
  • double J (JJ) stent

    		•
    Experimental: tubeless

    only JJ stent

    Device: nephrostomy tube
    we will investigate if a nephrostomy tube or JJ stent really necessary after PNL operations
    Other Names:
  • double J (JJ) stent

    		•
    Experimental: nephrostomy tube

    nephrostomy tube

    Device: nephrostomy tube
    we will investigate if a nephrostomy tube or JJ stent really necessary after PNL operations
    Other Names:
  • double J (JJ) stent

    		•

    Outcome Measures

    Primary Outcome Measures

    1. postoperative pain [6 months]

      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.

    2. postoperative urine leakage [6 months]

      Researchers will investigate whether there is a difference in urine leakage between the three groups by measuring the number of pads changed daily.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bursa City Hospital Bursa Turkey 16110

    Sponsors and Collaborators

    • Bursa City Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    abdullah erdogan, associate professor, Bursa City Hospital
    ClinicalTrials.gov Identifier:
    NCT06062849
    Other Study ID Numbers:
    • 2019-KAEK-140 / 2023-12/2
    First Posted:
    Oct 2, 2023
    Last Update Posted:
    Oct 2, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by abdullah erdogan, associate professor, Bursa City Hospital
    percutaneous nephrolithotomy
    nephrostomy tube
    double J stent
    Additional relevant MeSH terms:
    Kidney Calculi
    Nephrolithiasis
    Calculi

    Study Results

    No Results Posted as of Oct 2, 2023