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

Last updated: November 4, 2023
Sponsor: Bursa City Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Post-surgical Pain

Kidney Stones

Treatment

totally tubless

double J stent

nephrostomy tube

Clinical Study ID

NCT06062849
2019-KAEK-140 / 2023-12/2
  • Ages 18-100
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: totally tubless
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
February 01, 2024

Study 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.

Connect with a study center

  • Bursa City Hospital

    Bursa, 16110
    Turkey

    Active - Recruiting

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