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.
Inclusion Criteria:
Individuals age 6 or older
Diagnosis of kidney stone disease (nephrolithiasis)
Asymptomatic, non-obstructive kidney stones measuring 4 to 10 mm (inclusive)
Informed consent and if appropriate, child assent.
Willingness to be randomized to surgery or observation Note: subjects otherwise eligible who decline randomization may be enrolled in a parallel observational cohort.
Fluent in English or Spanish
Willingness to be audio- and/or video- recorded during interviews
Exclusion Criteria:
mccuner@chop.edu267-909-6030
Allocation concealment will be achieved by having the randomization performed centrally at the Data Coordinating Center (DCC) in REDCap, with randomly permuted blocks of 4, 6, and 8 to minimize the risk of allocation bias. Additionally, we will require participant details to be entered into the system before the randomly allocated treatment is revealed. Blinding will not be possible for participants or investigators providing the treatment (observation or upfront surgery). Members of the Outcome Adjudication Committee will be blinded to group assignment. The principal investigators will not have access to participant level information.
augellib@chop.edu609-504-4908
CaOx Stone Prevention
UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones
Empiric Versus Selective Prevention Strategies for Kidney Stone Disease
Protocol No. 2016 - Calculosis- Endourology;
Evaluation of Pain Before and After Removal of Non-obstructive Kidney Stones
Pediatric KIDney Stone (PKIDS) Care Improvement Network
Access Sheath and Stent Trial
Quality of Life in Kidney Stone Patients Undergoing Surgery