Urolithiasis Clinical Trial
Official title:
Single-center Randomized Study Evaluating Feasibility of Routine Bladder Catheterization After Mini- Percutaneous Nephrolithotripsy (PCNL)
NCT number | NCT04570787 |
Other study ID # | 04/20-? |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2020 |
Est. completion date | April 1, 2022 |
60 patients 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)
Status | Recruiting |
Enrollment | 60 |
Est. completion date | April 1, 2022 |
Est. primary completion date | February 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - 18 to 70 years - 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: - Active urinary tract infection - Coagulopathy - Clinically significant infravesical obstruction (Qmax less than 10 ml / s, PVR more than 50 ml) |
Country | Name | City | State |
---|---|---|---|
Russian Federation | First Pavlov Saint Petersburg University | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
St. Petersburg State Pavlov Medical University |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To measure the level of pain in patients | Filling out the VASP score after PCNL by all patients in 2, 6, 12 and 24 hours | 1 day | |
Secondary | To register the AE regarding catheterization or absence of catheterization | Performing ultrasound examination of urinary bladder after PCNL, | 1 day |
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