Effectiveness of Holmium and Thulium Lasers With Ureteroscopy for Urinary Lithiasis

• Conditions: Ureteral Stone; Renal Stone

• Registration Number: NCT04871984
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-25
• Status Verified: 2021-05
• Study Start: 2021-05
• Primary Completion: 2021-05
• Study First Submitted QC: 2021-05-02
• Last Update Submitted: 2021-05-02
• Study First Posted: 2021-05-04
• Last Update Posted: 2021-05-04
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stone free rate	Three months after surgery	Urinary tract echography or renal computer tomography imaging. Patients with residual fragments under 4 mm are stone free.

Secondary Outcome Measures

Name	Time	Method
Operating time	Immediately after the intervention	All surgeries are included
Postoperative complications	Up to three months after surgery	Recording data according to the Clavien classification (rates of hospitalisation, pain, infection and surgical revision)
Perioperative complications	During the intervention	Recording data about ureteric perforation and bleeding