Kidney StoneNCT05591716
Evaluation of the Efficacy and Safety of Unimodal Bilateral Flexible Ureteroscopy.
A study testing Bilateral same-session flexible ureterorenoscopy and Unilateral same-session flexible ureterorenoscopy in people with Kidney Stone, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial summary
This is a prospective controlled study to compare the efficacy and safety of two methods of flexible urethroscopy in patients with urolithiasis, as well as the effect of surgery on quality of life. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Bilateral same-session flexible ureterorenoscopy and Unilateral same-session flexible ureterorenoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteRussia
- Study dates
- 17 Oct 2022to 17 May 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single and bilateral kidney stones with a total 20 mm or less on each side
- Over 18 years of age
- Signed informed consent
Who cannot join
- Patients with large stones (total size greater than 20 mm) and coral stones
- Urethral and ureteral strictures
- Urinary tract abnormalities
- Unwillingness to sign informed consent
- Presence of active urinary tract infection
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Saint-Petersburg State University Hospital
Saint Petersburg, 190103
Alexander MD Petrov, +79302001480, urology@spbpetrov.ru
Ivan Gorgotsky, +7 960 269-63-43, igorgotsky@gmail.com
About this study
Official title: Evaluation of the Efficacy and Safety of Unimodal Bilateral Flexible Ureteroscopy A Prospective Multicenter Study
This is a prospective controlled study to compare the efficacy and safety of two methods of flexible urethroscopy in patients with urolithiasis, as well as the effect of surgery on quality of life.
Read the detailed description
Retrograde flexible URS is the most modern and safe method of treating patients with bowel stones up to 20 mm. Bilateral kidney stones can be treated with bilateral retrograde flexible URS. This type of surgery allows a patient to get rid of both kidney stones in a single intervention. Technically, the operation can be performed alternately on each side or simultaneously by two surgeons if two flexible instruments and video endoscopic racks are available simultaneously. Flexible ureteroscope diameter of 7.5-9 Сh enables to place two instruments even in the male urethra simultaneously without significant traumatization. One of the disadvantages of this method is the need for bilateral prestenting, with the frequency and the frequency and severity of stent-associated symptoms may increase. Few scientific works demonstrate contradictory data concerning the safety of bilateral flexible URS; therefore, further research is advisable.
All patients meeting the selection criteria will undergo preoperative examination: history, physical, laboratory and CT scan of the kidneys.
MATERIALS AND METHODS To calculate the sample, the investigators used the method for "no lesser efficiency" studies. To confirm the hypothesis of no greater number of complications in the form of upper urinary tract mucosal damage, exit (extravasation) of irrigation solution outside the upper urinary tract, bleeding and perforation of the ureteral wall, which according to the literature are 11.9% for bilateral and 8.5% for unilateral RIRH respectively, a minimum of 82 patients would be required in order to study of 80% and a probability of first-order error of 5% to exclude a 20% difference in the number of complications, which is clinically significant. To compensate for data loss, the sample size is increased by 5% to 86 patients. Categorical variables will be reported as absolute numbers and percentages. Unadapted univariate analyses, to compare the two treatment groups, will be based on Fisher's exact test. Relative risks and 95% confidence intervals will be calculated using the two-by-two table method using a logarithmic approximation. Continuous variables will be displayed as mean ± standard deviation or median and interquartile range.Pre- and postoperative data collected will be anonymized using unique codes that patients will receive immediately after randomization.
All surgical procedures will be performed by 3 qualified surgeons. Postoperative follow-up will be performed 1 day,1 month after surgery by two investigators, a non-blinded study.
- Conditions
- Kidney Stone
- Being tested
- Bilateral same-session flexible ureterorenoscopy, Unilateral same-session flexible ureterorenoscopy
- Keywords
- urolithias, flexible urethroscopy, bilateral flexible urethroscopy, lazer
- 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 same-session flexible ureterorenoscopyProcedure or surgery
The patient was in the lithotomic position. A semi-rigid ureteroscope was passed into the bladder, then a roadrunner was placed. A flexible urethroscope is guided along the roadrunner to the kidney. In the kidney, the concrement is fragmented with laser energy. The fragments were extracted using a basket. Then a revision of the kidney is performed using a flexible urethroscope. A ureteral stent was placed in the pelvis.The ureteroscope was extracted together with the case with the ureteral revision: there was no damage to the ureter.Next, this procedure is performed from the other side. Urine was excreted from the bladder using a Nelaton catheter.
Unilateral same-session flexible ureterorenoscopyProcedure or surgery
The patient was in the lithotomic position. A semi-rigid ureteroscope was passed into the bladder, then a roadrunner was placed. A flexible urethroscope is guided along the roadrunner to the kidney. In the kidney, the concrement is fragmented with laser energy. The fragments were extracted using a basket. Then a revision of the kidney is performed using a flexible urethroscope. A ureteral stent was placed in the pelvis. The ureteroscope was extracted together with the body with revision of the ureter: there was no damage to the ureter. Urine was excreted from the bladder using a Nelaton catheter.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral flexible ureteroscopy | Active comparator | Transurethral removal of kidney stones Receives: Procedure: Unilateral same-session flexible ureterorenoscopy |
| Bilateral flexible ureteroscopy | Active comparator | Transurethral removal of kidney stones Receives: Procedure: Bilateral same-session flexible ureterorenoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective cure rate
The frequency of early postoperative complications according to Clavien-Dindo scale starting from the second stage more.
Measured: 1 day after surgery surgery
Secondary outcomes (5)
Assessment of kidney performance
Assessment of plasma creatinine level
Measured: 1 day after surgery surgery
Assessment of the inflammatory process
body temperature
Measured: 1 day after surgery surgery
Postoperative examination
Leukocyte count
Measured: 1 day after surgery surgery
Evaluation residual stones
Hydronephrosis and residual stones according to according to ultrasound of kidneys
Measured: 1 month after surgery surgery
Evaluation stone free rate
CT scan kidneys
Measured: 3 month after surgery surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start17 Oct 2022
- Primary completion17 Feb 2023 (estimated)
- Study completion17 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nariman.gadjiev, Saint Petersburg State University, Russia
- Investigators
- Nariman Gadjiev, PhD, Study chair, Saint Petersburg State University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591716
- Sponsor's protocol ID
- Uni_or_bilateral
- Status last verified
- Nov 2022
- First submitted
- 19 Oct 2022
- Last updated
- 16 Nov 2022
- 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 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Unimodal Bilateral Flexible Ureteroscopy A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT05591716
- Acronym / sponsor ID
- Uni_or_bilateral
- Conditions
- Kidney Stone
- Keywords
- urolithias, flexible urethroscopy, bilateral flexible urethroscopy, lazer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 17 Feb 2023 (estimated)
- Study completion
- 17 May 2023 (estimated)
- First posted
- 24 Oct 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.
This is a prospective controlled study to compare the efficacy and safety of two methods of flexible urethroscopy in patients with urolithiasis, as well as the effect of surgery on quality of life.
Detailed description
Retrograde flexible URS is the most modern and safe method of treating patients with bowel stones up to 20 mm. Bilateral kidney stones can be treated with bilateral retrograde flexible URS. This type of surgery allows a patient to get rid of both kidney stones in a single intervention. Technically, the operation can be performed alternately on each side or simultaneously by two surgeons if two flexible instruments and video endoscopic racks are available simultaneously. Flexible ureteroscope diameter of 7.5-9 Сh enables to place two instruments even in the male urethra simultaneously without significant traumatization. One of the disadvantages of this method is the need for bilateral prestenting, with the frequency and the frequency and severity of stent-associated symptoms may increase. Few scientific works demonstrate contradictory data concerning the safety of bilateral flexible URS; therefore, further research is advisable.
All patients meeting the selection criteria will undergo preoperative examination: history, physical, laboratory and CT scan of the kidneys.
MATERIALS AND METHODS To calculate the sample, the investigators used the method for "no lesser efficiency" studies. To confirm the hypothesis of no greater number of complications in the form of upper urinary tract mucosal damage, exit (extravasation) of irrigation solution outside the upper urinary tract, bleeding and perforation of the ureteral wall, which according to the literature are 11.9% for bilateral and 8.5% for unilateral RIRH respectively, a minimum of 82 patients would be required in order to study of 80% and a probability of first-order error of 5% to exclude a 20% difference in the number of complications, which is clinically significant. To compensate for data loss, the sample size is increased by 5% to 86 patients. Categorical variables will be reported as absolute numbers and percentages. Unadapted univariate analyses, to compare the two treatment groups, will be based on Fisher's exact test. Relative risks and 95% confidence intervals will be calculated using the two-by-two table method using a logarithmic approximation. Continuous variables will be displayed as mean ± standard deviation or median and interquartile range.Pre- and postoperative data collected will be anonymized using unique codes that patients will receive immediately after randomization.
All surgical procedures will be performed by 3 qualified surgeons. Postoperative follow-up will be performed 1 day,1 month after surgery by two investigators, a non-blinded study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral flexible ureteroscopy | Active comparator | Procedure: Unilateral same-session flexible ureterorenoscopyTransurethral removal of kidney stones |
| Bilateral flexible ureteroscopy | Active comparator | Procedure: Bilateral same-session flexible ureterorenoscopyTransurethral removal of kidney stones |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Single and bilateral kidney stones with a total 20 mm or less on each side
- Over 18 years of age
- Signed informed consent
Key exclusion criteria (6 listed)
- Patients with large stones (total size greater than 20 mm) and coral stones
- Urethral and ureteral strictures
- Urinary tract abnormalities
- Unwillingness to sign informed consent
- Presence of active urinary tract infection
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 same-session flexible ureterorenoscopyThe patient was in the lithotomic position. A semi-rigid ureteroscope was passed into the bladder, then a roadrunner was placed. A flexible urethroscope is guided along the roadrunner to the kidney. In the kidney, the concrement is fragmented with laser energy. The fragments were extracted using a basket. Then a revision of the kidney is performed using a flexible urethroscope. A ureteral stent was placed in the pelvis.The ureteroscope was extracted together with the case with the ureteral revision: there was no damage to the ureter.Next, this procedure is performed from the other side. Urine was excreted from the bladder using a Nelaton catheter. | Procedure or surgery | Bilateral flexible ureteroscopy |
| Unilateral same-session flexible ureterorenoscopyThe patient was in the lithotomic position. A semi-rigid ureteroscope was passed into the bladder, then a roadrunner was placed. A flexible urethroscope is guided along the roadrunner to the kidney. In the kidney, the concrement is fragmented with laser energy. The fragments were extracted using a basket. Then a revision of the kidney is performed using a flexible urethroscope. A ureteral stent was placed in the pelvis. The ureteroscope was extracted together with the body with revision of the ureter: there was no damage to the ureter. Urine was excreted from the bladder using a Nelaton catheter. | Procedure or surgery | Unilateral flexible ureteroscopy |
Primary outcome
Objective cure rate
Time frame: 1 day after surgery surgery
The frequency of early postoperative complications according to Clavien-Dindo scale starting from the second stage more.
5 secondary outcomes
Assessment of kidney performance
Time frame: 1 day after surgery surgery
Assessment of the inflammatory process
Time frame: 1 day after surgery surgery
Postoperative examination
Time frame: 1 day after surgery surgery
Evaluation residual stones
Time frame: 1 month after surgery surgery
Evaluation stone free rate
Time frame: 3 month after surgery surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
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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.
Nariman Gadjiev, PhD study chair
Saint Petersburg State University 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 Bilateral same-session flexible ureterorenoscopy and Unilateral same-session flexible ureterorenoscopy in people with Kidney Stone, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
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 3 inclusion and 6 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 16 Nov 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 Russia. 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 Alexander MD Petrov (+79302001480, urology@spbpetrov.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective cure rate (time frame: 1 day after surgery 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 16 Nov 2022.