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

Not Applicable

• Conditions: Urolithiasis
• Interventions: Procedure: reusable digital flexible ureteroscope; Procedure: single use digital ureteroscope; Procedure: reusable fiberoptic ureteroscope

• 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.

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-01
• Study First Submitted QC: 2017-07-16
• Last Update Submitted: 2017-07-16
• Study First Posted: 2017-07-18
• Last Update Posted: 2017-07-18
• Study Start: 2017-08
• Primary Completion: 2020-09
• Study Completion: 2020-09

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

Arm && Interventions

Group	Intervention	Description
reusable digital flexible ureteroscopes	reusable digital flexible ureteroscope	Participants under this arm will undergo the RIRS procedure under the reusable digital flexible ureteroscope.
single-use digital ureteroscope	single use digital ureteroscope	Participants under this arm will undergo retrograde intrarenal surgery (RIRS) procedure under the single use digital ureteroscope.
reusable fiberoptic ureteroscopes	reusable fiberoptic ureteroscope	Participants under this arm will undergo the RIRS procedure under the reusable fiberoptic ureteroscope

Primary Outcome Measures

Name	Time	Method
cost of surgery	intraoperative	the total cost of the procedure

Secondary Outcome Measures

Name	Time	Method
operative time	intraoperative
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