International Multi-center Profile of Emergency Large-Bowel Obstruction Management and Outcomes (IMPEL)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- 30 day morbidity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Functional or pseudo-obstruction without a mechanical lesion
- •Pediatric patients (<18 years)
- •Patients not admitted to hospital
- •Isolated large-bowel perforation unrelated to obstruction
研究组 & 干预措施
All IMPEL patients
All enrolled participants with mechanical large-bowel obstruction managed according to local standard-of-care practices.
结局指标
主要结局
30 day morbidity
时间窗: From hospital admission date or date of surgery (whichever is later) to 30 days later.
Occurrence of postoperative complications within 30 days of hospital day zero (baseline) or date of surgery, graded using the Clavien-Dindo classification.
次要结局
- 30 day mortality(30 days)
- Stoma creation(From hospital day 0 (baseline) to 90 days.)
- Stoma reversal(from hospital discharge (baseline) to 6 months)
- Length of hospital stay(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.(From index admission (day 0) to 30 days (for 30-day outcomes).)
- Use of minimally invasive surgical approach(Index surgical procedure)
- Number of participants with self expanding metallic stents.(From hospital day 0 (baseline) up to 90 days)
- Unplanned readmission(From initial inpatient hospitalization (baseline) up to 90 days)
- Patient-reported assessment of gastrointestinal recovery(From day 0 (baseline) up to 30 days.)
研究者
Matteo Cimino
IMPEL Study Coordinator
European Society for Trauma and Emergency Surgery