Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:54 AM
Study NCT ID:
NCT07458867
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
International Multi-center Profile of Emergency Large-Bowel Obstruction Management and Outcomes
Sponsor:
European Society for Trauma and Emergency Surgery
Organization:
Study Overview
Official Title:
International Multi-center Profile of Emergency Large-Bowel Obstruction Management and Outcomes (IMPEL)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPEL
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: