International Multi-center Profile of Emergency Large-Bowel Obstruction Management and Outcomes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Society for Trauma and Emergency Surgery

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 1 trial group
Group A: All IMPEL patients

Trial outcomes

Primary outcomes

1

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.

Time frame
From hospital admission date or date of surgery (whichever is later) to 30 days later.

Secondary outcomes

1

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.

Time frame
30 days
2

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).

Time frame
From hospital day 0 (baseline) to 90 days.
3

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.

Time frame
from hospital discharge (baseline) to 6 months
4

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.

Time frame
From hospital day 0 (baseline) to dischagre in a time frame of 90 days.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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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