Urolithiasis Clinical Trial
Official title:
Dusting vs Basketing in RIRS: a Single-center Prospective Randomised Trial
The investigator aims to perform a prospective and randomized controlled trial comparing the safety and efficacy of active basket extraction of fragments and stone dusting during the RIRS.
Status | Recruiting |
Enrollment | 136 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients must be a suitable operative candidate for RIRS 2. Age =18 years 3. Normal renal function 4. ASA score ? and ? 5. Single renal stone =20mm or multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) up to 20 mm Exclusion Criteria: 1. Pregnant subjects 2. Uncorrected coagulopathy and active urinary tract infection (UTI) 3. prior ipsilateral endourological procedure history, such as RIRS, PCNL, URS and URL 4. Patients who underwent transplant or urinary diversion. 5. Congenital abnormalities. |
Country | Name | City | State |
---|---|---|---|
China | Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guohua Zeng |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stone free rate (SFR) | To assess for stone-free rate using K.U.B. (kidney-ureter-bladder) plain radiograph and renal ultrasound. If there is a discrepancy in follow up imaging between the presence of residual stones or fragments between the KUB and renal ultrasound, the KUB will be considered the reference standard for small fragments less than 4mm unless the stone composition is uric acid. If fragments 5 mm or larger exist or uric acid it will be up to the discretion of the surgeon to order a CT to better delineate the presence of residual stones and their impact on the clinical management of that patient. | 4-6 weeks after surgery | |
Secondary | Operating time | from starting fragmentation to placement of stent (DJ stent or ureteral stent) unless no stent is needed | intraoperatively | |
Secondary | Complication rates | Complication such as fever, pain, urosepsis etc. | intraoperatively or 48h postoperatively |
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