Treatment Outcome Clinical Trial
Official title:
The Effect of Renal Access Sheath Size Used During Percutaneous Nephrolithotomy on Postoperative Renal Functions
Verified date | December 2022 |
Source | Bakirkoy Dr. Sadi Konuk Research and Training Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 functions. After dilatation, 22French (Fr) Amplatz sheath will be placed in the first group, while 28Fr Amplatz sheath will be placed in the second group. The functional difference will be evaluated with preoperative and postoperative 3rd-month kidney scintigraphies (diethylenetriamine pentaacetic acid (DTPA) and technetium-99m dimercaptosuccinic acid (DMSA). In addition, Kidney Injury Molecule-1 (KIM-1) levels will be measured in the urine in order to be a predictor of functional loss in the early period.
Status | Active, not recruiting |
Enrollment | 88 |
Est. completion date | January 1, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Bakirköy Dr. Sadi Konuk Training and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Bakirkoy Dr. Sadi Konuk Research and Training Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differential function changes | Differential function changes in the operated kidney in postoperative DMSA and DTPA | 3 months | |
Primary | Newly developed scar | Presence of newly developed scar in DMSA | 3 months | |
Primary | KIM-1 | Change in urinary KIM-1 levels | 24 hours | |
Secondary | Creatinine | Postoperative changes in creatinine | 24 hours | |
Secondary | Glomerular filtration rate | Postoperative changes in glomerular filtration rate | 24 hours | |
Secondary | Stone-free rate | Postoperative stone-free rates | 24 hours | |
Secondary | Complications | Complications according to Clavian grading | 30 days |
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