N/A
N=180
Comparing Treatment of Urolithiasis Between Disposable and Reusable Ureteroscope
Kidney Calculi · Ureter Calculi
Bottom Line
View on ClinicalTrials.gov: NCT03040466 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Overall Procedure Time — 64.5; 54.1 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- reusable fiberoptic ureteroscope (Device); disposable digital ureteroscope (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Procedure Time |
64.5; 54.1 | — |
| SECONDARY Number of Participants That Are Stone Free |
17; 24 | — |
| SECONDARY Number of Participants With Complications |
9; 9 | — |
Summary
Reusable flexible ureteroscopes are widely used to treat various upper urinary tract diseases including urinary stones. However, they require a long turnover time between procedures because of the sterilization process. Moreover, repeated use of a scope ultimately deteriorates its image quality which leads to a high maintenance cost in the long-term. A disposable digital flexible ureteroscope was released in the United States in January 2016, offering an improved image resolution, new scope performance characteristics with every case, and no need for sterilization and repair. Preliminary data from our center has demonstrated that disposable scopes shorten operative time by 25% compared to reusable fiberoptic scope and are associated with a 2/3 reduction in procedural complication rate. Therefore, treatment with disposable scopes may be more effective for patients and facilitate cost management within the hospital.
Here, we propose a three-armed, prospective randomized study, comparing treatment outcomes between disposable digital, reusable fiberoptic, and reusable digital flexible ureteroscopes.
Eligibility Criteria
Inclusion Criteria
- Male or female ≥ 18 years of age at their first clinical visit.
- Patients with either unilateral or bilateral upper urinary tract stone of any size and location, treatable by flexible ureteroscopy, diagnosed by preoperative ultrasound, computed tomography or plain radiographic imaging
- Patients being able and willing to provide consent.
Exclusion Criteria
- Serious illness likely to cause death within the next 5 years, so as to exclude significant metabolic derangements that might lead to adverse surgical outcome.
- Pregnancy.
- Staged ureteroscopic procedure.
- Antegrade flexible ureteroscopy.
- Dual procedures (ureteroscopy concurrently performed with other operations).
Data sourced from ClinicalTrials.gov (NCT03040466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.