Observational Approach Versus Surgical Intervention for Stones
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Surgery, Observation.
- Кому может быть актуально
- Состояния в реестре: Nephrolithiasis, Kidney Stone. Базовые параметры: от 6 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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:
1. Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits. 2. 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.
Observational Cohort (Non-Randomized Cohort):
Up to 300 eligible subjects who are willing to consent to data collection but refuse randomization will be enrolled and followed for two years.
Study Design OASIS is a pragmatic randomized controlled superiority trial conducted at approximately 30 sites that participate in Patient Centered Outcomes Research Network (PCORnet). The trial will include an additional observational cohort for eligible subjects who decline randomization.
Вмешательства
- Процедура Surgery
Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy and shockwave lithotripsy, which are routinely used in standard clinical care. - Другое Observation
Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.
Первичные конечные точки
- Healthcare-related life disruption [Срок оценки: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.]
Вторичные конечные точки (7)
- Patient reported physical and emotional health (Pain Interference) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.]
- Stone passage [Срок оценки: 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) [Срок оценки: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.]
- Lost productivity (Caregiver Missed Work) [Срок оценки: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.]
- Lost productivity (Patient Missed Work) [Срок оценки: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- The Children's Hospital of Philadelphia — Philadelphia
Идентификаторы
NCT: NCT07718802 · 26-024242 · BPS-2025C1-44653