International Multi-center Profile of Emergency Large-Bowel Obstruction Management and Outcomes
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Large Bowel Obstruction. Базовые параметры: от 18 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
International Multi-center Profile of Emergency Large-Bowel Obstruction Management and Outcomes (IMPEL)
Обзор
Mechanical large-bowel obstruction is a common and high-risk emergency surgical condition with substantial variation in diagnostic evaluation, operative timing, and management strategies across institutions and healthcare systems. Evidence guiding optimal management remains limited and is largely derived from retrospective or single-center studies. IMPEL is an international, multicenter, time-bound, prospective observational cohort study designed to characterize real-world presentation, diagnostic pathways, operative and non-operative management, and short-term outcomes in adults presenting with mechanical large-bowel obstruction. By capturing standardized patient-level, radiologic, operative, and outcome data across diverse acute care settings, IMPEL aims to describe contemporary practice patterns, quantify variation in care, and identify factors associated with morbidity, mortality, and stoma-related outcomes.
Подробное описание
IMPEL is a prospective, non-randomized, observational snapshot audit conducted across international acute care hospitals managing emergency general surgery. Participating centers enroll consecutive adult patients presenting with mechanical large-bowel obstruction during a predefined 90-day inclusion period within a six-month global study window.
Patients are managed according to local standard practice; no interventions are assigned by the study protocol. Data collected include baseline characteristics and comorbidity burden, clinical frailty, diagnostic imaging features, operative and non-operative management strategies (including bridge-to-surgery approaches), perioperative outcomes, and short-term follow-up outcomes. Stoma creation, intent, and reversal status are recorded, with follow-up to six months for stoma outcomes.
The study is structured in accordance with STROBE guidelines for observational research. Analyses addressing comparative or causal questions will follow target trial emulation principles, including explicit definition of eligibility, time zero, treatment strategies, and estimands, without implying interventional assignment.
IMPEL is intended to provide a contemporary international reference standard for the management of large-bowel obstruction, inform future interventional studies, and support quality improvement and guideline development efforts.
Первичные конечные точки
- 30 day morbidity [Срок оценки: From hospital admission date or date of surgery (whichever is later) to 30 days later.]
Вторичные конечные точки (9)
- 30 day mortality [Срок оценки: 30 days]
- Stoma creation [Срок оценки: From hospital day 0 (baseline) to 90 days.]
- Stoma reversal [Срок оценки: from hospital discharge (baseline) to 6 months]
- Length of hospital stay [Срок оценки: From hospital day 0 (baseline) to dischagre in a time frame of 90 days.]
- Association of admitting specialty and on-call model with clinical outcomes and care processes. [Срок оценки: From index admission (day 0) to 30 days (for 30-day outcomes).]
- Use of minimally invasive surgical approach [Срок оценки: Index surgical procedure]
- Number of participants with self expanding metallic stents. [Срок оценки: From hospital day 0 (baseline) up to 90 days]
- Unplanned readmission [Срок оценки: From initial inpatient hospitalization (baseline) up to 90 days]
- Patient-reported assessment of gastrointestinal recovery [Срок оценки: From day 0 (baseline) up to 30 days.]
Критерии участия
Критерии включения
- Age 18 years or older
- Hospital admission with mechanical large-bowel obstruction, with or without associated perforation
- Managed operatively or non-operatively according to local standard practice
Критерии исключения
- Functional or pseudo-obstruction without a mechanical lesion
- Pediatric patients (<18 years)
- Patients not admitted to hospital
- Isolated large-bowel perforation unrelated to obstruction
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07458867 · IMPEL