Evaluation of the Efficacy and Safety of Unimodal Bilateral Flexible Ureteroscopy.
1 other identifier
interventional
86
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2022
CompletedFirst Submitted
Initial submission to the registry
October 19, 2022
CompletedFirst Posted
Study publicly available on registry
October 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2023
CompletedNovember 16, 2022
November 1, 2022
4 months
October 19, 2022
November 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Assessment of kidney performance
1 day after surgery surgery
Assessment of the inflammatory process
1 day after surgery surgery
Postoperative examination
1 day after surgery surgery
Evaluation residual stones
1 month after surgery surgery
Evaluation stone free rate
3 month after surgery surgery
Study Arms (2)
Unilateral flexible ureteroscopy
ACTIVE COMPARATORTransurethral removal of kidney stones
Bilateral flexible ureteroscopy
ACTIVE COMPARATORTransurethral removal of kidney stones
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Single and bilateral kidney stones with a total 20 mm or less on each side
- Over 18 years of age
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint-Petersburg State University Hospital
Saint Petersburg, 190103, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nariman Gadjiev, PhD
Saint Petersburg State University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D., Deputy Director for medical care (urology), Urologist of Saint Petersburg State University Clinic of advanced medical technologies n.a. N.I.Pirogov.
Study Record Dates
First Submitted
October 19, 2022
First Posted
October 24, 2022
Study Start
October 17, 2022
Primary Completion
February 17, 2023
Study Completion
May 17, 2023
Last Updated
November 16, 2022
Record last verified: 2022-11