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

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: Recruiting
• Conditions: Kidney Stone
• Intervention / Treatment: Procedure: Unilateral same-session flexible ureterorenoscopy; Procedure: Bilateral same-session flexible ureterorenoscopy

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: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander MD Petrov; Phone Number: +79302001480; Email: urology@spbpetrov.ru
• Study Contact Backup: Name: Ivan MD Gorgotsky, PhD; Phone Number: +7 960 269-63-43; Email: igorgotsky@gmail.com

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 190103
    • Recruiting
    • Saint-Petersburg State University Hospital
    • Contact: Alexander MD Petrov; Phone Number: +79302001480; Email: urology@spbpetrov.ru
    • Contact: Ivan Gorgotsky; Phone Number: +7 960 269-63-43; Email: igorgotsky@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Objective cure rate	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

Outcome Measure	Measure Description	Time Frame
Assessment of kidney performance	Assessment of plasma creatinine level	1 day after surgery surgery
Assessment of the inflammatory process	body temperature	1 day after surgery surgery
Postoperative examination	Leukocyte count	1 day after surgery surgery
Evaluation residual stones	Hydronephrosis and residual stones according to according to ultrasound of kidneys	1 month after surgery surgery
Evaluation stone free rate	CT scan kidneys	3 month after surgery surgery

Collaborators and Investigators

• Sponsor: St. Petersburg State Pavlov Medical University
• Investigators: Study Chair: Nariman Gadjiev, PhD, Saint-Petersburg State University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Anticipated): February 17, 2023
• Study Completion (Anticipated): May 17, 2023

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: urolithias; flexible urethroscopy; bilateral flexible urethroscopy; lazer
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Nephrolithiasis; Kidney Calculi
• Other Study ID 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