Laser Lithotripsy During Ureteroscopy - Holmium vs Thulium: A Clinical Prospective Randomized Trial of Effectiveness and Safety
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urolithiasis
- Sponsor
- Haukeland University Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Stone Free Rate
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The aim of the study is to compare URS lithotripsy performed with Holmium:YAG laser and Thulium Fiber Laser.
The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser.
The outcomes of the URS procedures are compared for the two treatment arms.
Detailed Description
The primary aim of the study is to compare the stone free rate (SFR) following URS lithotripsy with Holmium and Thulium lasers. SFRs will be compared both for ureteral stones, renal stones and ureteral and renal stones in total. Secondary aims are to compare the results of the two lasers in terms of operating times, intraoperative complications, postoperative complications and the rate of post endoscopic JJ-stenting. The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser. The outcomes of the URS procedures are compared for the two treatment arms.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients planned for ureteroscopic treatment of ureteral and renal stones at the Day Surgery Unit at Haukeland University Hospital, Bergen, Norway
Exclusion Criteria
- •Known pathology of the upper urinary tract
- •Untreated infection
Outcomes
Primary Outcomes
Stone Free Rate
Time Frame: 3 months after the URS
Evaluation of stone free status on CT scan following URS. Stone free status is defined as no residual fragments.
Secondary Outcomes
- Operating Time(Decided immediately after the surgery)
- Intraoperative Complications(Decided immediately after the surgery)
- Postoperative Complications(Within 3 months post endoscopically)
- Postoperative JJ-stenting(Decided immediately after the surgery)