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NCT Number: NCT07458867

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

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.

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Key information

Conditions

Large Bowel Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 30 day morbidity

    Time frame: 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.

Secondary outcomes

  1. 30 day mortality

    Time frame: 30 days

    All-cause mortality occurring within 30 days of date of hospital admission (day zero) for mechanical large-bowel obstruction, irrespective of management strategy.

  2. Stoma creation

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

    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).

  3. Stoma reversal

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

    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.

  4. Length of hospital stay

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

    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.

  5. Association of admitting specialty and on-call model with clinical outcomes and care processes.

    Time frame: From index admission (day 0) to 30 days (for 30-day outcomes).

    Clinical outcomes and care processes, including 30-day major morbidity (Clavien-Dindo grade ≥III), 30-day mortality, time (in hours) from hospital admission(baseline, day zero) to definitive intervention, and stoma creation, will be evaluated in Association to admitting specialty (emergency surgery vs colorectal surgery vs other) and the hospital's out-of-hours emergency general surgery coverage model (dedicated emergency surgery service vs elective subspecialty rota).

  6. Use of minimally invasive surgical approach

    Time frame: Index surgical procedure

    Use of a minimally invasive surgical approach (laparoscopic, robotic, or hybrid), including conversion to open surgery where applicable, during operative management of large-bowel obstruction.

  7. Number of participants with self expanding metallic stents.

    Time frame: From hospital day 0 (baseline) up to 90 days

    Use of self expanding metallic stent before surgical resection in patients with colonic obstruction.

  8. Unplanned readmission

    Time frame: From initial inpatient hospitalization (baseline) up to 90 days

    Unplanned hospital readmission related to complications or sequelae of large-bowel obstruction or its management.

  9. Patient-reported assessment of gastrointestinal recovery

    Time frame: From day 0 (baseline) up to 30 days.

    Patient-Reported Outcomes of Gastrointestinal Recovery (PRO-diGI) will be used to assess appetite, oral intake, bowel function, nausea/vomiting, abdominal pain, fatigue, and overall gastrointestinal wellbeing using ordered categorical items and a 0-100 visual analogue scale (0=worst, 100=best). Where feasible within routine workflows, PRO-diGI will be administered at prespecified time points.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriele Bellio, MD

CONTACT

[email protected]

Matteo M Cimino, MD

CONTACT

[email protected]

+393928811420

Sponsors and collaborators

Lead sponsor

European Society for Trauma and Emergency Surgery

Other

Collaborators

  • American Society of Colon and Rectal Surgeons
  • Association of Surgeons of Great Britain and Ireland
  • European Society of Coloproctology
  • University of Pennsylvania

Registry information

Official study title

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

Acronym: IMPEL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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