Kidney CalculiNCT06062849
Is it Really Necessary to Insert a Nephrostomy Tube or Double J Stent in Percutaneous Nephrolithotomy?
A study testing nephrostomy tube, double J stent and totally tubless in people with Kidney Calculi and Postoperative Pain, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, investigators aimed to compare the postoperative pain status and comfort situations depending on instruments used in the percutaneous nephrolithotomy operation Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Kidney Calculi, Postoperative Pain
- What is being tested?
- nephrostomy tube, double J stent and totally tubless
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and above
- Larger than 2 cm kidney stones
Who cannot join
- Under 18 years of age
- Anatomical anomalies (horseshoe kidney, ectopic kidney, ureteropelvic junction stenosis, ureteral stenosis),
- Uncorrectable bleeding diathesis
- Bilateral kidney stones
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa City Hospital
Bursa, 16110
Abdullah Erdogan, MD, +905362665256
About this study
In this study, investigators aimed to compare the postoperative pain status and comfort situations depending on instruments used in the percutaneous nephrolithotomy operation
Read the 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.
- Conditions
- Kidney Calculi, Postoperative Pain
- Being tested
- nephrostomy tube, double J stent, totally tubless
- Keywords
- percutaneous nephrolithotomy, nephrostomy tube, double J stent
- Medical subject headings
- Kidney Calculi, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nephrostomy tubeDevice
we will investigate if a nephrostomy tube really necessary after PNL operations
double J stentDevice
we will investigate if a JJ stent really necessary after PNL operations
totally tublessProcedure or surgery
Also called there is no device
we will not insert any device after the procedure and investigate if a nephrostomy tube or JJ stent really necessary after PNL operations
| Study group | Role | What they receive |
|---|---|---|
| totally tubeless | Active comparator | there is no nephrostomy tube or double J (JJ) stent Receives: Procedure: totally tubless |
| tubeless | Active comparator | only JJ stent Receives: Device: double J stent |
| nephrostomy tube | Experimental | nephrostomy tube Receives: Device: nephrostomy tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Aug 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, abdullah erdogan, Bursa City Hospital
- Investigators
- Sedat Oner, MD, Study director, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062849
- Sponsor's protocol ID
- 2019-KAEK-140 / 2023-12/2
- Status last verified
- Nov 2023
- First submitted
- 13 Sep 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Really Necessary to Insert a Nephrostomy Tube or Double J Stent in Percutaneous Nephrolithotomy?
- ClinicalTrials.gov ID
- NCT06062849
- Acronym / sponsor ID
- 2019-KAEK-140 / 2023-12/2
- Conditions
- Kidney Calculi, Postoperative Pain
- Keywords
- percutaneous nephrolithotomy, nephrostomy tube, double J stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| totally tubeless | Active comparator | Procedure: totally tublessthere is no nephrostomy tube or double J (JJ) stent |
| tubeless | Active comparator | Device: double J stentonly JJ stent |
| nephrostomy tube | Experimental | Device: nephrostomy tubenephrostomy tube |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 years and above
- Larger than 2 cm kidney stones
Key exclusion criteria (4 listed)
- Under 18 years of age
- Anatomical anomalies (horseshoe kidney, ectopic kidney, ureteropelvic junction stenosis, ureteral stenosis),
- Uncorrectable bleeding diathesis
- Bilateral kidney stones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nephrostomy tubewe will investigate if a nephrostomy tube really necessary after PNL operations | Device | nephrostomy tube |
| double J stentwe will investigate if a JJ stent really necessary after PNL operations | Device | tubeless |
| totally tublessAlso: there is no devicewe will not insert any device after the procedure and investigate if a nephrostomy tube or JJ stent really necessary after PNL operations | Procedure or surgery | totally tubeless |
Primary outcome
postoperative pain
Time frame: 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.
postoperative urine leakage
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sedat Oner, MD study director
Bursa City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nephrostomy tube, double J stent and totally tubless in people with Kidney Calculi and Postoperative Pain, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdullah Erdogan, MD (+905362665256, dr.abderd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.