Observational Approach Versus Surgical Intervention for Stones
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,658
- 试验地点
- 3
- 主要终点
- Healthcare-related life disruption
研究概览
简要总结
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.
详细描述
A critical barrier to improving the health of the nearly 40 million Americans with kidney stone disease is the weak evidence base supporting the management of individuals with asymptomatic kidney stones. The proposed Observational Approach versus Surgical Intervention for Asymptomatic Stone (OASIS) randomized clinical trial answers the research question of whether observation or upfront surgery results in less life disruption from asymptomatic kidney stones for children and adults. The management options for patients with asymptomatic stones are 1) observation or 2) upfront surgical treatment, both of which are considered safe, part of usual care, widely accessible, and covered by insurance.
OASIS responds to the charge for well-designed Randomized Controlled Trials (RCT) from the Agency for Healthcare Research and Quality (AHRQ) systematic review on kidney stone disease management and ensures patient centeredness by examining outcomes that patients have identified as meaningful.
Intervention
Randomization to either:
- Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.
- Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy (URS) and shockwave lithotripsy (SWL), which are routinely used in standard clinical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Untreated hydronephrosis or caliectasis
- •Pain (e.g., renal colic, abdominal pain) or gross hematuria attributed to kidney stones.
- •Recurrent symptomatic urinary tract infections (≥3 in 12 months or ≥2 in 6 months). A symptomatic urinary tract infection is defined as having at least one bladder or voiding symptom (e.g., frequency, urgency, dysuria) with bacteriuria (≥105 colony forming units/mL of no more than 2 urinary tract pathogens).
- •Stone in the renal pelvis, ureter, bladder or urethra
- •Pregnant females
- •Solitary kidney, transplant kidney, urinary diversion, medullary sponge kidney
- •Anatomic abnormality of the kidney (e.g., horseshoe kidney)
- •Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
研究组 & 干预措施
Randomized
干预措施: Surgery (Procedure)
Non-Randomized (Observational)
干预措施: Surgery (Procedure)
Non-Randomized (Observational)
干预措施: Observation (Other)
Randomized
干预措施: Observation (Other)
结局指标
主要结局
Healthcare-related life disruption
时间窗: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Composite of: Stone-specific emergency department (ED)/urgent care visits, stone-specific hospitalizations and surgery for stones for new symptoms (Shockwave Lithotripsy (SWL) and Ureteroscopy (URS)) as reported via Patient Centered Outcomes Research Network (PCORnet) Common Data Model (CDM) query and participant self-report on REDCap.
次要结局
- Patient reported physical and emotional health (Pain Interference)(Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.)
- Patient reported physical and emotional health (Anxiety)(Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.)
- Patient reported physical and emotional health (Stone Quality of Life)(Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.)
- Stone passage(Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months. Reporting total after 2 years.)
- Lost productivity (Missed School)(Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.)
- Lost productivity (Caregiver Missed Work)(Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.)
- Lost productivity (Patient Missed Work)(Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.)