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Single-use Digital Flexible Ureteroscope vs Nondisposable Fiber Optic vs Digital Ureteroscope

Not Applicable
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
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
cost of surgeryintraoperative

the total cost of the procedure

Secondary Outcome Measures
NameTimeMethod
stone free rate3months after surgery
Stone free rate1month after surgery
operator's satisfaction with the scopeintraoperative

on the scope or 1-10

complication ratesupto 3months
operative timeintraoperative

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