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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date November 2021
Source St. Petersburg State Pavlov Medical University
Contact Dmitry S Gorelov
Phone +79217964892
Email dsgorelov@mail.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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)


Description:

60 patients after PCNL will be recruited and randomized into 2 groups (30 vs 30): - 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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Urinary bladder catheterisation
Installation of Foley catheter into the urinary bladder

Locations

Country Name City State
Russian Federation First Pavlov Saint Petersburg University Saint Petersburg

Sponsors (1)

Lead Sponsor Collaborator
St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

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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