Observational Approach Versus Surgical Intervention for Stones
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.
• Individuals age 6 or older
• Diagnosis of kidney stone disease (nephrolithiasis)
• Asymptomatic, non-obstructive kidney stones measuring 4 to 10 mm (inclusive)
‣ Asymptomatic is defined as the absence of abdominal pain, flank pain, gross hematuria, and nausea and/or vomiting in the last 3 months that in the judgement of the site PI could be attributable to kidney stones.
⁃ Non-obstructive is defined as a stone in a renal calyx or stones in multiple renal calyces on CT, ultrasound, and/or x-ray obtained within 6 months of screening.
• 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