Status:
UNKNOWN
Effect of Renal Access Sheath on Functions
Lead Sponsor:
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Conditions:
Kidney Function Tests
Treatment Outcome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Patients will be randomly divided into two groups in order to evaluate the effect of the size of the access sheath (Amplatz) used in the Percutaneous Nephrolithotomy (PCNL) operation on kidney functio...
Detailed Description
PCNL has been applied for the last 30 years as the primary and most effective treatment method in patients with kidney stones of 2 cm or larger. The primary purpose of the operation is to ensure stone...
Eligibility Criteria
Inclusion
- Patients with 2-3 cm kidney stones
- Patients with an American Society of Anesthesiologists ≤2 score
- BMI: Patients between 20 and 35 kg/m2
Exclusion
- Patients with preoperative renal failure
- Patients with multiple access
- Patients undergone renal transplantation
- Patients with renal anomalies (horseshoe kidney, solitary kidney, double collecting system, etc.)
- Patients with history of open kidney stones surgery and/or PCNL history
- Patients who cannot be stone-free in the postoperative period (fragments \>4 mm in imaging) and require additional treatment intervention
- Patients with bleeding disorders
- Pregnant patients
- Patients with complete staghorn stones
- Patients with bilateral obstructive stones
- Patients with active infection
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05232188
Start Date
December 1 2020
End Date
January 1 2023
Last Update
December 13 2022
Active Locations (1)
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1
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Turkey (Türkiye)