Kidney Stone, Kidney Calculi, Ureteral Calculi, Ureterolithiasis, Urolithiasis
Conditions
Keywords
Lithotripsy, Extracorporeal shockwave lithotripsy
Brief summary
A comparison on the outcomes of patients undergoing shockwave lithotripsy using the Storz machine versus the Dornier machine.
Detailed description
This is a single institution, prospective randomized controlled clinical trial comparing two lithotriper machines (the Storz Modulith LX-F2 and Dornier Delta III) in patients who are undergoing shockwave lithotripsy (SWL) as the primary management of their urinary stone. Patients record pain score on day of operation and post-operative day 1, and are followed for 1 month until they receive standard of care imaging at 1 month post-operatively.
Interventions
PROCEDURELithotripter
Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Cleveland Clinic Foundation patients planned for elective SWL with a preoperative CT performed * Age ≥ 18 years old * Male and female patients * Patients of all ethnic backgrounds * Stone size 5-15mm * Stone location: Renal or proximal ureter * Stone density: \< 1200 Hounsfield Units * Skin to stone distance: \< 12cm * Primary treatment for a solitary stone (must be previously untreated) Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study.
Exclusion criteria
* Prior treatment for specified stone * Multiple stones on treatment side (even if only one is treated) * Anticoagulated or history of coagulopathy * Prior ureteral stent placement * Technical problems/impossibility of localizing the stone on the day of intervention Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone free rate | Four weeks post operative | Presence of stone on follow up imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluoroscopy time | Intra-operative | Length of fluoroscopy exposure |
| Treatment Time | Intra-operative | Length of surgical procedure |
| Pain Scores | Four days post-operative | Response to visual analog scale |
| Complication Rates | One month post-operative | Medical complications |
| Secondary Interventions required | One month post-operative | Follow up surgery |
Countries
United States
Outcome results
None listed