Surgery vs Observation for Kidney Stones
(OASIS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The aims of the Observational Approach versus Surgical Intervention for Asymptomatic Stone (OASIS) trial are: 1) to determine whether observation compared to upfront surgery results in less healthcare-related life disruption due to kidney stones among children and adults with asymptomatic kidney stones; 2) to identify the groups benefiting the most from each strategy; and 3) to determine the preferences and values informing the choice between observation and upfront surgery.
Who Is on the Research Team?
Gregory E Tasian, MD, MSc, MSCE
Principal Investigator
Children's Hospital of Philadelphia
Are You a Good Fit for This Trial?
This trial is for children and adults (age 6+) with kidney stones that are not causing symptoms like pain or blood in urine. Stones must be small (4-10 mm), located only in the kidney, and not blocking urine flow. Participants must speak English or Spanish and agree to random assignment or observation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observation
Surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits
Upfront Surgery
Planned removal of asymptomatic stones including ureteroscopy (URS) and shockwave lithotripsy (SWL)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Observation
- Surgery
Trial Overview
The study compares two approaches for people with symptom-free kidney stones: having surgery right away versus simply monitoring the stones without immediate treatment. Participants are randomly assigned to either group, unless they choose just to be observed.
How Is the Trial Designed?
2
Treatment groups
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital of Philadelphia
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
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