About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Functional or pseudo-obstruction without a mechanical lesion
Pediatric patients (<18 years)
Patients not admitted to hospital
Isolated large-bowel perforation unrelated to obstruction
Trial population
The study population comprises consecutive adults (≥18 years) admitted to participating acute care hospitals with a diagnosis of mechanical large-bowel obstruction, with or without associated large-bowel perforation attributable to obstruction. Patients are enrolled irrespective of management strategy (operative or non-operative), and care is delivered according to local standard practice. Participating sites include international hospitals providing emergency general surgery care. Enrollment occurs during a predefined 90-day consecutive inclusion period selected by each site within a global six-month study window, with follow-up through 30 days for postoperative outcomes and through 6 months for stoma-related outcomes.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
30 day morbidity
Occurrence of postoperative complications within 30 days of hospital day zero (baseline) or date of surgery, graded using the Clavien-Dindo classification.
Secondary outcomes
30 day mortality
All-cause mortality occurring within 30 days of date of hospital admission (day zero) for mechanical large-bowel obstruction, irrespective of management strategy.
Stoma creation
Creation of any intestinal stoma during the index admission for mechanical large-bowel obstruction, including stoma type and intended purpose (defunctioning anastomosis; bridge to definitive resection; non-restorative/palliative; or damage-control).
Stoma reversal
Number of reversal (closure) of any diverting or end stoma, created during the index admission, within 6 months of hospital discharge, assessed through routine clinical follow-up and medical record review.
Length of hospital stay
Duration of the index hospital admission day 0 (baseline) to discharge of the patients from the hospital. The event dischage is defined as the day when the patients quit the hospital of the index admission, for these reasons: he's sent home, he's sent to another hospital, he dies dies. This measure in expressed in days.
Locations
Sponsors and contacts
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European Society for Trauma and Emergency Surgery
Lead sponsor
Association of Surgeons of Great Britain and Ireland
Collaborator
European Society of Coloproctology
Collaborator
American Society of Colon and Rectal Surgeons
Collaborator
University of Pennsylvania
Collaborator
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