NCT04871984
Unknown
Not Applicable
Ureteroscopy for Upper Tract Lithiasis : Comparison of Costs and Effectiveness of Both Holmium and Thulium Lasers, in a Prospective Monocentric Study.
University Hospital, Angers0 sites200 target enrollmentMay 2021
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Stone
- Sponsor
- University Hospital, Angers
- Enrollment
- 200
- Primary Endpoint
- Stone free rate
- Last Updated
- 4 years ago
Overview
Brief Summary
Holmium laser is the current gold standard for lithotripsy on urinary lithiasis, while Thulium is brand new. The latter has been released in July 2020 in Europe, and only in-vitro studies have been published.
The aim of this study is to compare the stone free rate in ureteroscopy, for all consecutive patients treated with laser fragmentation, between both Holmium and Thulium lasers.
The costs and complications will also be studied.
Investigators
Eligibility Criteria
Inclusion Criteria
- •renal ou ureteral stone confirmed by an abdominal and pelvic computed tomography
- •treatment with rigid or flexible ureteroscopy
- •laser lithotripsy during the procedure
- •bacteriological examination of urine (sterile, bacterial colonization or treated by antibiotics)
Exclusion Criteria
- •non-use of laser for stone lithotripsy
- •pregnant women
- •under 18 years old
- •refusal to give informed consent
- •urinary malformation
Outcomes
Primary Outcomes
Stone free rate
Time Frame: Three months after surgery
Urinary tract echography or renal computer tomography imaging. Patients with residual fragments under 4 mm are stone free.
Secondary Outcomes
- Operating time(Immediately after the intervention)
- Postoperative complications(Up to three months after surgery)
- Perioperative complications(During the intervention)
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