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

NCT07458867 | Not Yet Recruiting DMC

• 1 other identifier: IMPEL
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Large Bowel Obstruction

Keywords

Large-bowel obstruction; stoma; colonic obstruction; bridge to surgery; snapshot audit; observational cohort

Outcome Measures

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.

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

Secondary Outcomes (9)

• 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).

Study Arms (1)

All IMPEL patients

All enrolled participants with mechanical large-bowel obstruction managed according to local standard-of-care practices.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Functional or pseudo-obstruction without a mechanical lesion
• Pediatric patients (\<18 years)
• Patients not admitted to hospital
• Isolated large-bowel perforation unrelated to obstruction

Sponsors & Collaborators

• American Society of Colon and Rectal Surgeons: collaborator
• European Society for Trauma and Emergency Surgery: lead
• Association of Surgeons of Great Britain and Ireland: collaborator
• European Society of Coloproctology: collaborator
• University of Pennsylvania: collaborator

Study Officials

• Gary A Bass, MD, PhD

  University of Pennsylvania

  STUDY DIRECTOR

Central Study Contacts

Matteo M Cimino, MD

CONTACT

+393928811420; cimino.matteo@gmail.com

Gabriele Bellio, MD

CONTACT

gabrielebellio87@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IMPEL Study Coordinator

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: March 9, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 5 years
• Access Criteria: By reasonable request to PI