Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02522689 |
Date of registration:
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09/08/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Comparison of Ultra-mini PCNL and Micro PCNL
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Scientific title:
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Comparison of Success Rates, Complication Rates and Injury to Kidneys of Ultra-mini PCNL and Micro PCNL in the Treatment of Kidney Stones |
Date of first enrolment:
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October 8, 2019 |
Target sample size:
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60 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02522689 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Ozcan Kilic, M.D. |
Address:
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Telephone:
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+905074196189 |
Email:
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drozcankilic@yahoo.com |
Affiliation:
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Name:
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Ozcan Kilic, M.D. |
Address:
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Telephone:
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+905074196189 |
Email:
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drozcankilic@yahoo.com |
Affiliation:
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Name:
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Ozcan Kilic, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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Selcuk University, School of Medicine, Department of Urology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who are planned to undergo PCNL due to kidney stone
- Patients with a kidney stone < 2 cm
- Patients between 18 and 65 years old
Exclusion Criteria:
- Patients with unregulated diabetes mellitus and diabetic nephropathy
- Patients with a blood pressure higher than 140/80 mmHg despite use of antihypertensive
drug(s) regularly
- Patients with chronic renal failure who need dialysis
- Patients who had prerenal, renal or postrenal acute kidney failure during the last 6
months
- Patients who had acute pyelonephritis during the last 6 months
- Patients younger than 18 years old or older than 65 years old
- Patients who had kidney surgery during the last 3 months and who have abnormal kidney
functions
- Patients with ureteral stone who are planned to undergo endoscopic stone treatment at
the same time
- Patients with a history of corticosteroid use during enrollment into the study or
previous 3 months
- Patients with uncontrolled thyroid disease
- Patients who have a disease with rapid cell turn-over (like leukemia, lymphoma, etc.)
- Patients whose operation terminated or converted to open surgery due to any reason
- Patients with missing data
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Kidney Stones
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Intervention(s)
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Procedure: Endoscopic kidney stone surgery
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Primary Outcome(s)
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Stone-free rate
[Time Frame: Within the first 30 days after surgery.]
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Secondary Outcome(s)
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Blood Cystatin C level (mg/L)
[Time Frame: Within the first 12 hours after surgery.]
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Urine Cystatin C level (mg/L)
[Time Frame: Within the first 12 hours after surgery.]
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Complication rate
[Time Frame: Within the first 30 days after surgery.]
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Secondary ID(s)
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SU-PCNL-UMMP-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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