Urolithiasis
Conditions
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.
Interventions
PROCEDUREsingle use digital ureteroscope
All participants in this arm will undergo RIRS using a single use digital ureteroscope.
PROCEDUREreusable fiberoptic ureteroscope
All participants under this arm will undergo RIRS using a reusable fiberoptic ureteroscope
PROCEDUREreusable digital flexible ureteroscope
All participants under this arm will undergo RIRS using reusable digital flexible ureteroscope
Sponsors
Dr. Lufti KIRDAR Kartal Research and training Hospital, Instanbul, Turkey
Siloam St.Trudpert Hospital
Guohua Zeng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cost of surgery | intraoperative | the total cost of the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | intraoperative | on the scope or 1-10 |
Contacts
Primary ContactWei Zhu, PhD
Backup ContactIrene Ketegwe, MBBS
Outcome results
None listed