Urolithiasis Clinical Trial
Official title:
A Prospective Randomized Study Comparing Single-use Digital Flexible Ureteroscope, Nondisposable Fiber Optic and Digital Ureteroscope in Treatment of Upper Urinary Stone Less Than 2 cm
The aim of this trial is to compare the safety, efficacy and cost effectiveness of the three types of scopes.
Status | Not yet recruiting |
Enrollment | 450 |
Est. completion date | September 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Aged 18-70 years 2. American society of Anesthesiology (ASA) score 1 and 2 3. Renal or upper ureteral stone of diameter = 2.0 cm Exclusion Criteria: 1. Ureteral stricture, renal or ureteral deformity 2. Pregnancy 3. Patients with chronic kidney disease, CKD (serum creatine> 177 umol/L) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Guohua Zeng | Dr. Lufti KIRDAR Kartal Research and training Hospital, Instanbul, Turkey, Siloam St.Trudpert Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cost of surgery | the total cost of the procedure | intraoperative | |
Secondary | Stone free rate | 1month after surgery | ||
Secondary | stone free rate | 3months after surgery | ||
Secondary | complication rates | upto 3months | ||
Secondary | operative time | intraoperative | ||
Secondary | operator's satisfaction with the scope | on the scope or 1-10 | intraoperative |
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