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

Primary Purpose

Kidney Calculi, Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
nephrostomy tube
Sponsored by
Bursa City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Calculi focused on measuring percutaneous nephrolithotomy, nephrostomy tube, double J stent

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bursa City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

totally tubeless

tubeless

nephrostomy tube

Arm Description

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

only JJ stent

nephrostomy tube

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2023
Last Updated
September 28, 2023
Sponsor
Bursa City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06062849
Brief Title
Is it Really Necessary to Insert a Nephrostomy Tube or Double J Stent in Percutaneous Nephrolithotomy?
Official Title
Is it Really Necessary to Insert a Nephrostomy Tube or Double J Stent in Percutaneous Nephrolithotomy?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi, Postoperative Pain
Keywords
percutaneous nephrolithotomy, nephrostomy tube, double J stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
totally tubeless
Arm Type
Experimental
Arm Description
there is no nephrostomy tube or double J (JJ) stent
Arm Title
tubeless
Arm Type
Experimental
Arm Description
only JJ stent
Arm Title
nephrostomy tube
Arm Type
Experimental
Arm Description
nephrostomy tube
Intervention Type
Device
Intervention Name(s)
nephrostomy tube
Other Intervention Name(s)
double J (JJ) stent
Intervention Description
we will investigate if a nephrostomy tube or JJ stent really necessary after PNL operations
Primary Outcome Measure Information:
Title
postoperative pain
Description
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.
Time Frame
6 months
Title
postoperative urine leakage
Description
Researchers will investigate whether there is a difference in urine leakage between the three groups by measuring the number of pads changed daily.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdullah Erdogan, MD
Phone
+905362665256
Email
dr.abderd@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sedat Oner, MD
Phone
+905056726545
Email
sedatoner@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sedat Oner, MD
Organizational Affiliation
Bursa City Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Bursa City Hospital
City
Bursa
ZIP/Postal Code
16110
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdullah Erdogan, MD
Phone
+905362665256

12. IPD Sharing Statement

Learn more about this trial

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

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