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

Study Overview
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Brief Summary
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The aim of this trial is to compare the safety, efficacy and cost effectiveness of the three types of scopes.

Detailed Description
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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.

Official Title
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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

Conditions
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Urolithiasis

Intervention / Treatment
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* Procedure: single use digital ureteroscope
* Procedure: reusable fiberoptic ureteroscope
* Procedure: reusable digital flexible ureteroscope


Participation Criteria
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Eligibility Criteria
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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 Pregnancy Patients with chronic kidney disease, CKD (serum creatine> 177 umol/L)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-use digital ureteroscope<br>Participants under this arm will undergo retrograde intrarenal surgery (RIRS) procedure under the single use digital ureteroscope. | Procedure: single use digital ureteroscope<br>* All participants in this arm will undergo RIRS using a single use digital ureteroscope.<br>|
| Experimental: reusable fiberoptic ureteroscopes<br>Participants under this arm will undergo the RIRS procedure under the reusable fiberoptic ureteroscope | Procedure: reusable fiberoptic ureteroscope<br>* All participants under this arm will undergo RIRS using a reusable fiberoptic ureteroscope<br>|
| Experimental: reusable digital flexible ureteroscopes<br>Participants under this arm will undergo the RIRS procedure under the reusable digital flexible ureteroscope. | Procedure: reusable digital flexible ureteroscope<br>* All participants under this arm will undergo RIRS using reusable digital flexible ureteroscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost of surgery | the total cost of the procedure | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate |  | 1month after surgery | 
| stone free rate |  | 3months after surgery | 
| complication rates |  | upto 3months | 
| operative time |  | intraoperative | 
| operator's satisfaction with the scope | on the scope or 1-10 | intraoperative |