Evaluation of the Efficacy and Safety of Unimodal Bilateral Flexible Ureteroscopy.

November 11, 2022 updated by: nariman.gadjiev, St. Petersburg State Pavlov Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Single and bilateral kidney stones with a total 20 mm or less on each side
  • Over 18 years of age
  • Signed informed consent

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Unilateral flexible ureteroscopy
Transurethral removal of kidney stones
Procedure: Unilateral same-session flexible ureterorenoscopy
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.
Active Comparator: Bilateral flexible ureteroscopy
Transurethral removal of kidney stones
Procedure: Bilateral same-session flexible ureterorenoscopy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 day after surgery surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of kidney performance
Time Frame: 1 day after surgery surgery
Assessment of plasma creatinine level
1 day after surgery surgery
Assessment of the inflammatory process
Time Frame: 1 day after surgery surgery
body temperature
1 day after surgery surgery
Postoperative examination
Time Frame: 1 day after surgery surgery
Leukocyte count
1 day after surgery surgery
Evaluation residual stones
Time Frame: 1 month after surgery surgery
Hydronephrosis and residual stones according to according to ultrasound of kidneys
1 month after surgery surgery
Evaluation stone free rate
Time Frame: 3 month after surgery surgery
CT scan kidneys
3 month after surgery surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Petersburg State Pavlov Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Nariman Gadjiev, PhD, Saint-Petersburg State University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 17, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Uni_or_bilateral

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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