Stone, KidneyNCT05340075
Staged Bilateral Percutaneous Nephrolithotomy
An observational study of Stone, Kidney and Urolithiasis, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To determine the optimal time between the first and second operations in patients with bilateral kidney stones and scheduled percutaneous nephrolithotomy for the contralateral kidney. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stone, Kidney, Urolithiasis
- What is being tested?
- Patients who underwent percutaneous nephrolithotomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2021to 20 Jan 2022
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stones of 2 cm or more in each kidney
Who may be able to join
- Patients with stones of 2 cm or more in each kidney
Who cannot join
- Renal Failure
- Coagulopathy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, Altindag, 06230
About this study
Official title: Staged Bilateral Percutaneous Nephrolithotomy: When to Operate for a Contralateral Kidney?
To determine the optimal time between the first and second operations in patients with bilateral kidney stones and scheduled percutaneous nephrolithotomy for the contralateral kidney. Patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the first operation will be compared.
Read the detailed description
The aim of the study is to determine the optimal time between the first and second operations in patients with bilateral kidney stones and scheduled percutaneous nephrolithotomy for the contralateral kidney. In our study, patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the first operation will be compared. With the guidance of preoperative and postoperative data, it is aimed to determine the optimal time with the lowest complication and highest operational success.
- Conditions
- Stone, Kidney, Urolithiasis
- Being tested
- Patients who underwent percutaneous nephrolithotomy
- Medical subject headings
- Kidney Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients who underwent percutaneous nephrolithotomyProcedure or surgery
Patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the percutaneous nephrolithotomy operation
| Study group | Role | What they receive |
|---|---|---|
| Staged percutaneous nephrolithotomy group 1 | Those who underwent percutaneous nephrolithotomy 2-4 weeks after percutaneous nephrolithotomy for stones in the other kidney Receives: Procedure: Patients who underwent percutaneous nephrolithotomy | |
| Staged percutaneous nephrolithotomy group 2 | Those who underwent percutaneous nephrolithotomy 4-6 weeks after percutaneous nephrolithotomy for stones in the other kidney Receives: Procedure: Patients who underwent percutaneous nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI in kg/m^2
BMI in kg/m^2
Measured: 3 Months
rates of intraoperative blood transfusion, operation time(minute)
rates of intraoperative blood transfusion, operation time(minute)
Measured: 3 Months
Secondary outcomes (1)
mm size of the stone,
mm size of the stone,
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start15 Sep 2021
- Primary completion15 Dec 2021
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stone, KidneyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Kaan Yildiz, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340075
- Sponsor's protocol ID
- PCNL2022
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wollin DA, Preminger GM. Percutaneous nephrolithotomy: complications and how to deal with them. Urolithiasis. 2018 Feb;46(1):87-97. doi: 10.1007/s00240-017-1022-x. Epub 2017 Nov 17.
PubMed 29149365ElSheemy MS, Ghoneima W, Elmarakbi AA, Al-Kandari AM, Ibrahim H, Shrestha S, Khadgi S. Bilateral Single-session vs Staged Mini-percutaneous Nephrolithotomy for Renal Stones: A Comparative Study. Urology. 2018 Oct;120:62-67. doi: 10.1016/j.urology.2018.07.015. Epub 2018 Jul 20.
PubMed 30031834Torricelli FCM, Carvalho RS, Marchini GS, Danilovic A, Vicentini FC, Batagello CA, Srougi M, Nahas WC, Mazzucchi E. Bilateral simultaneous percutaneous nephrolithotomy versus staged approach: a critical analysis of complications and renal function. Rev Assoc Med Bras (1992). 2020 Dec;66(12):1696-1701. doi: 10.1590/1806-9282.66.12.1696.
PubMed 33331579
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staged Bilateral Percutaneous Nephrolithotomy: When to Operate for a Contralateral Kidney?
- ClinicalTrials.gov ID
- NCT05340075
- Acronym / sponsor ID
- PCNL2022
- Conditions
- Stone, Kidney, Urolithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 21 Apr 2022 (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.
To determine the optimal time between the first and second operations in patients with bilateral kidney stones and scheduled percutaneous nephrolithotomy for the contralateral kidney. Patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the first operation will be compared.
Detailed description
The aim of the study is to determine the optimal time between the first and second operations in patients with bilateral kidney stones and scheduled percutaneous nephrolithotomy for the contralateral kidney. In our study, patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the first operation will be compared. With the guidance of preoperative and postoperative data, it is aimed to determine the optimal time with the lowest complication and highest operational success.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staged percutaneous nephrolithotomy group 1 | – | Procedure: Patients who underwent percutaneous nephrolithotomyThose who underwent percutaneous nephrolithotomy 2-4 weeks after percutaneous nephrolithotomy for stones in the other kidney |
| Staged percutaneous nephrolithotomy group 2 | – | Procedure: Patients who underwent percutaneous nephrolithotomyThose who underwent percutaneous nephrolithotomy 4-6 weeks after percutaneous nephrolithotomy for stones in the other kidney |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stones of 2 cm or more in each kidney
Key inclusion criteria (1 listed)
- Patients with stones of 2 cm or more in each kidney
Key exclusion criteria (3 listed)
- Renal Failure
- Coagulopathy
- Pregnancy
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 |
|---|---|---|
| Patients who underwent percutaneous nephrolithotomyPatients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the percutaneous nephrolithotomy operation | Procedure or surgery | Staged percutaneous nephrolithotomy group 1, Staged percutaneous nephrolithotomy group 2 |
Primary outcome
BMI in kg/m^2
Time frame: 3 Months
BMI in kg/m^2
rates of intraoperative blood transfusion, operation time(minute)
Time frame: 3 Months
rates of intraoperative blood transfusion, operation time(minute)
1 secondary outcome
mm size of the stone,
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Background: PubMed 29149365Wollin DA, Preminger GM. Percutaneous nephrolithotomy: complications and how to deal with them. Urolithiasis. 2018 Feb;46(1):87-97. doi: 10.1007/s00240-017-1022-x. Epub 2017 Nov 17.
- Background: PubMed 30031834ElSheemy MS, Ghoneima W, Elmarakbi AA, Al-Kandari AM, Ibrahim H, Shrestha S, Khadgi S. Bilateral Single-session vs Staged Mini-percutaneous Nephrolithotomy for Renal Stones: A Comparative Study. Urology. 2018 Oct;120:62-67. doi: 10.1016/j.urology.2018.07.015. Epub 2018 Jul 20.
- Background: PubMed 33331579Torricelli FCM, Carvalho RS, Marchini GS, Danilovic A, Vicentini FC, Batagello CA, Srougi M, Nahas WC, Mazzucchi E. Bilateral simultaneous percutaneous nephrolithotomy versus staged approach: a critical analysis of complications and renal function. Rev Assoc Med Bras (1992). 2020 Dec;66(12):1696-1701. doi: 10.1590/1806-9282.66.12.1696.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stone, Kidney and Urolithiasis, run by Ankara Training and Research 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 21 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI in kg/m^2 (time frame: 3 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?
On the ClinicalTrials.gov record for NCT05340075, which also lists 3 linked publications.
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 21 Apr 2022.