Kidney CalculiNCT03599297
Bilateral Synchronous Simultaneous Stone Surgery
A study testing Bilateral synchronous simultaneous stone surgery in people with Kidney Calculi and Nephrolithotomy, Percutaneous, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Advancements in technology and endourological armamentarium provides multiple surgical options for complicated stone patients. To avoid multiple operations and shorten the total operation durations, bilateral synchronous simultaneous stone surgery (BSSSS) has been popularized in recent years. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Calculi, Nephrolithotomy, Percutaneous, Ureteroscopy
- What is being tested?
- Bilateral synchronous simultaneous stone surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for kidney stone surgery according to European Association Urology, Urolithiasis guidelines
- patients with bilateral kidney stones
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Hospital
Istanbul, 34890
Yiloren Tanidir, Ass.Prof., 00905325694275, yiloren@yahoo.com
Tarik Emre Sener, M.D., 00905337620712, dr.emresener@gmail.com
About this study
Official title: Evaluation of Efficacy and Safety Profile of Bilateral Synchronous Simultaneous Stone Surgery for Kidney Stones
Advancements in technology and endourological armamentarium provides multiple surgical options for complicated stone patients. To avoid multiple operations and shorten the total operation durations, bilateral synchronous simultaneous stone surgery (BSSSS) has been popularized in recent years.
Our aim is to evaluate the preliminary outcomes of BSSSS in patients undergoing supine percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS).
- Conditions
- Kidney Calculi, Nephrolithotomy, Percutaneous, Ureteroscopy
- Being tested
- Bilateral synchronous simultaneous stone surgery
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral synchronous simultaneous stone surgeryProcedure or surgery
Patients undergoing Bilateral synchronous simultaneous stone surgery (one kidney undergoing percutaneous nephrolithotomy, other kidney undergoing ureteroscopy at the same time in a single patient)
| Study group | Role | What they receive |
|---|---|---|
| Bilateral synchronous simultaneous stone surgery | Experimental | Patients who will be operated for kidney stones at both their kidneys in a single surgery session will be included in the study. Patients will undergo percutaneous nephrolithotomy for one side and flexible ureteroscopy for the other side. Receives: Procedure: Bilateral synchronous simultaneous stone surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
stone free status is decided according to both the immediate evaluation of the endoscopic view at the end of the operation and the post operative imaging with kidney, ureter, bladder X-ray at the 24th hour of the surgery
Measured: at the 24th hour of the surgery
Secondary outcomes (6)
Complications
Complications are assessed according to Clavien Dindo classification
Measured: at the 1st week of surgery
Post operative urinary diversion
evaluation of patients whether they have a nephrostomy or a ureteral stent at the end of the operation
Measured: at the 24th hour of surgery
Radiation exposure
The cumulative fluoroscopy dose that was emitted during surgery
Measured: At 1st hour of surgery
Hemoglobin level change
The amount of hemoglobin drop during and after surgery
Measured: from baseline to 24th hour of surgery
Hospital stay
The amount of days that the patient stayed at the hospital
Measured: will be assessed through completion of study, an average of 1 year.
Residual stone
The diameter of the stones that couldn't be retracted
Measured: at the 24th hour of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2023 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yiloren Tanidir, Ass. Prof., Principal investigator, Marmara University, School of Medicine, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599297
- Sponsor's protocol ID
- MAR.UAD.003
- Status last verified
- Aug 2023
- First submitted
- 4 Jun 2018
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety Profile of Bilateral Synchronous Simultaneous Stone Surgery for Kidney Stones
- ClinicalTrials.gov ID
- NCT03599297
- Acronym / sponsor ID
- MAR.UAD.003
- Conditions
- Kidney Calculi, Nephrolithotomy, Percutaneous, Ureteroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 26 Jul 2018 (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.
Advancements in technology and endourological armamentarium provides multiple surgical options for complicated stone patients. To avoid multiple operations and shorten the total operation durations, bilateral synchronous simultaneous stone surgery (BSSSS) has been popularized in recent years.
Our aim is to evaluate the preliminary outcomes of BSSSS in patients undergoing supine percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral synchronous simultaneous stone surgery | Experimental | Procedure: Bilateral synchronous simultaneous stone surgeryPatients who will be operated for kidney stones at both their kidneys in a single surgery session will be included in the study. Patients will undergo percutaneous nephrolithotomy for one side and flexible ureteroscopy for the other side. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients scheduled for kidney stone surgery according to European Association Urology, Urolithiasis guidelines
- patients with bilateral kidney stones
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Bilateral synchronous simultaneous stone surgeryPatients undergoing Bilateral synchronous simultaneous stone surgery (one kidney undergoing percutaneous nephrolithotomy, other kidney undergoing ureteroscopy at the same time in a single patient) | Procedure or surgery | Bilateral synchronous simultaneous stone surgery |
Primary outcome
Stone free rate
Time frame: at the 24th hour of the surgery
stone free status is decided according to both the immediate evaluation of the endoscopic view at the end of the operation and the post operative imaging with kidney, ureter, bladder X-ray at the 24th hour of the surgery
6 secondary outcomes
Complications
Time frame: at the 1st week of surgery
Post operative urinary diversion
Time frame: at the 24th hour of surgery
Radiation exposure
Time frame: At 1st hour of surgery
Hemoglobin level change
Time frame: from baseline to 24th hour of surgery
Hospital stay
Time frame: will be assessed through completion of study, an average of 1 year.
Residual stone
Time frame: at the 24th hour of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No. The data will not be shared.
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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.
Yiloren Tanidir, Ass. Prof. principal investigator
Marmara University, School of Medicine, Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral synchronous simultaneous stone surgery in people with Kidney Calculi and Nephrolithotomy, Percutaneous, run by Marmara University 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 1 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 Aug 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 Yiloren Tanidir, Ass. Prof. (00905325694275, yiloren@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free rate (time frame: at the 24th hour of the surgery). 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 Aug 2023; AzTrials last refreshed its copy on 28 Oct 2026.