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Clinical Trials/NCT04871984
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.

Registry
clinicaltrials.gov
Start Date
May 2021
End Date
October 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Angers
Responsible Party
Sponsor

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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