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Clinical Trials/NCT03220516
NCT03220516
Unknown
Not Applicable

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

Guohua Zeng0 sites450 target enrollmentAugust 2017
ConditionsUrolithiasis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urolithiasis
Sponsor
Guohua Zeng
Enrollment
450
Primary Endpoint
cost of surgery
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2017
End Date
September 2020
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Guohua Zeng
Responsible Party
Sponsor Investigator
Principal Investigator

Guohua Zeng

Doctor and Proffesor

The First Affiliated Hospital of Guangzhou Medical University

Eligibility Criteria

Inclusion Criteria

  • Aged 18-70 years
  • American society of Anesthesiology (ASA) score 1 and 2
  • Renal or upper ureteral stone of diameter ≤ 2.0 cm

Exclusion Criteria

  • Ureteral stricture, renal or ureteral deformity
  • Patients with chronic kidney disease, CKD (serum creatine\> 177 umol/L)

Outcomes

Primary Outcomes

cost of surgery

Time Frame: intraoperative

the total cost of the procedure

Secondary Outcomes

  • stone free rate(3months after surgery)
  • Stone free rate(1month after surgery)
  • operator's satisfaction with the scope(intraoperative)
  • complication rates(upto 3months)
  • operative time(intraoperative)

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