Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2020-07-01
2022-04-01
Brief Summary
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Inclusion Criteria:
* age from 18 to 70 years
* Indications for mini-PCNL
* ASA score: 1-3
* Single percutaneous access to pyelocaliceal system
* Size of solitary calculus up to 2.5 cm
Exclusion Criteria:
* Active urinary tract infection
* Coagulopathy
* Clinically significant infravesical obstruction (Qmax less than 10 ml / s, PVR more than 50 ml)
Detailed Description
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* No Catheterization after mini-PCNL (study) - the bladder catheterization is not performed.
* Catheterization after mini-PCNL (control) - the bladder will be drained with the urethral catheter.
All patients will fill out the VASP in 2, 6, 12, 24 hours after mini-PCNL. Ultrasound examination of urinary bladder will be performed after mini-PCNL. All the AE will be registered.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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No Catheterization
After mini-PCNL standardized follow-up protocol supposes drainage the upper urinary tract with nephrostomy, tubeless (using ureteral stent without nephrostomy) or totally tubeless (no drainage) tactics. Bladder catheterization is not performed.
Urinary bladder catheterisation
Installation of Foley catheter into the urinary bladder
Catheterization
After mini-PCNL standardized follow-up protocol supposes drainage the upper urinary tract with nephrostomy, tubeless (using ureteral stent without nephrostomy) or totally tubeless (no drainage) tactics. The bladder is to be drained with the urethral catheter in all cases.
Urinary bladder catheterisation
Installation of Foley catheter into the urinary bladder
Interventions
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Urinary bladder catheterisation
Installation of Foley catheter into the urinary bladder
Eligibility Criteria
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Inclusion Criteria
* Indications for mini-PCNL
* ASA score: 1-3
* Single percutaneous access to pyelocaliceal system
* Size of solitary stone up to 2.5 cm
Exclusion Criteria
* Coagulopathy
* Clinically significant infravesical obstruction (Qmax less than 10 ml / s, PVR more than 50 ml)
18 Years
70 Years
ALL
No
Sponsors
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St. Petersburg State Pavlov Medical University
OTHER
Responsible Party
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Locations
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First Pavlov Saint Petersburg University
Saint Petersburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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Dmitriy Gorelov, MD
Role: primary
Other Identifiers
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04/20-н
Identifier Type: -
Identifier Source: org_study_id