Single-use Digital Flexible Ureteroscope vs Nondisposable Fiber Optic vs Digital Ureteroscope
- Conditions
- Urolithiasis
- Registration Number
- NCT03220516
- Lead Sponsor
- Guohua Zeng
- Brief Summary
The aim of this trial is to compare the safety, efficacy and cost effectiveness of the three types of scopes.
- Detailed Description
With the advancement of technology, flexible ureteroscopy (f-URS) has become an attractive option for surgical management of kidney stones. However, the durability of flexible ureteroscope still remains a major concern. Due to the high cost and limited durability, the cost-benefit of non-disposable flexible ureteroscope continues to be the most important factor for initiating and maintaining fURS programs worldwide, especially in the developing countries. Nowadays, disposable digital flexible ureteroscopes are available, offering an improved image resolution, no need for sterilization and repair, and more economic.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 450
- Aged 18-70 years
- American society of Anesthesiology (ASA) score 1 and 2
- Renal or upper ureteral stone of diameter ≤ 2.0 cm
- Ureteral stricture, renal or ureteral deformity
- Pregnancy
- Patients with chronic kidney disease, CKD (serum creatine> 177 umol/L)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method cost of surgery intraoperative the total cost of the procedure
- Secondary Outcome Measures
Name Time Method stone free rate 3months after surgery Stone free rate 1month after surgery operator's satisfaction with the scope intraoperative on the scope or 1-10
complication rates upto 3months operative time intraoperative