Large Bowel ObstructionIMPELNCT07458867
International Multi-center Profile of Emergency Large-Bowel Obstruction Management and Outcomes
An observational study of Large Bowel Obstruction, run by European Society for Trauma and Emergency Surgery.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Bowel Obstruction
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Jul 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Gabriele Bellio, MD contact
About this study
Official title: International Multi-center Profile of Emergency Large-Bowel Obstruction Management and Outcomes (IMPEL)
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.
Read the 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.
- Conditions
- Large Bowel Obstruction
- Keywords
- Large-bowel obstruction, stoma, colonic obstruction, bridge to surgery, snapshot audit, observational cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All IMPEL patients | All enrolled participants with mechanical large-bowel obstruction managed according to local standard-of-care practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From hospital admission date or date of surgery (whichever is later) to 30 days later.
Secondary outcomes (9)
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.
Measured: 30 days
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).
Measured: From hospital day 0 (baseline) to 90 days.
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.
Measured: from hospital discharge (baseline) to 6 months
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.
Measured: 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.
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).
Measured: From index admission (day 0) to 30 days (for 30-day outcomes).
Use of minimally invasive surgical approach
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.
Measured: Index surgical procedure
Number of participants with self expanding metallic stents.
Use of self expanding metallic stent before surgical resection in patients with colonic obstruction.
Measured: From hospital day 0 (baseline) up to 90 days
Unplanned readmission
Unplanned hospital readmission related to complications or sequelae of large-bowel obstruction or its management.
Measured: From initial inpatient hospitalization (baseline) up to 90 days
Patient-reported assessment of gastrointestinal recovery
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.
Measured: From day 0 (baseline) up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Bowel ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- European Society for Trauma and Emergency Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- Association of Surgeons of Great Britain and Ireland, European Society of Coloproctology, American Society of Colon and Rectal Surgeons, University of Pennsylvania
- Responsible party
- Principal investigator, Matteo Cimino, European Society for Trauma and Emergency Surgery
- Investigators
- Gary A Bass, MD, PhD, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458867
- Sponsor's protocol ID
- IMPEL
- Acronym
- IMPEL
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying published analyses from this study may be made available to qualified researchers on reasonable request, subject to approval by the IMPEL Steering Committee and compliance with applicable data protection regulations. Shared IPD will be limited to the minimum dataset necessary to address the approved research question and will exclude all direct identifiers. Data sharing will occur only after publication of the primary study results and under a data use agreement specifying the scope of use, authorship expectations, and data security requirements.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multi-center Profile of Emergency Large-Bowel Obstruction Management and Outcomes (IMPEL)
- ClinicalTrials.gov ID
- NCT07458867
- Acronym / sponsor ID
- IMPEL / IMPEL
- Conditions
- Large Bowel Obstruction
- Keywords
- Large-bowel obstruction, stoma, colonic obstruction, bridge to surgery, snapshot audit, observational cohort
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- European Society for Trauma and Emergency SurgeryUniversity, hospital or other
- Collaborators
- Association of Surgeons of Great Britain and Ireland, European Society of Coloproctology, American Society of Colon and Rectal Surgeons, University of Pennsylvania
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All IMPEL patients | – | –All enrolled participants with mechanical large-bowel obstruction managed according to local standard-of-care practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Functional or pseudo-obstruction without a mechanical lesion
- Pediatric patients (<18 years)
- Patients not admitted to hospital
- Isolated large-bowel perforation unrelated to obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
30 day mortality
Time frame: 30 days
Stoma creation
Time frame: From hospital day 0 (baseline) to 90 days.
Stoma reversal
Time frame: from hospital discharge (baseline) to 6 months
Length of hospital stay
Time frame: 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.
Time frame: From index admission (day 0) to 30 days (for 30-day outcomes).
Use of minimally invasive surgical approach
Time frame: Index surgical procedure
Number of participants with self expanding metallic stents.
Time frame: From hospital day 0 (baseline) up to 90 days
Unplanned readmission
Time frame: From initial inpatient hospitalization (baseline) up to 90 days
Patient-reported assessment of gastrointestinal recovery
Time frame: From day 0 (baseline) up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying published analyses from this study may be made available to qualified researchers on reasonable request, subject to approval by the IMPEL Steering Committee and compliance with applicable data protection regulations. Shared IPD will be limited to the minimum dataset necessary to address the approved research question and will exclude all direct identifiers. Data sharing will occur only after publication of the primary study results and under a data use agreement specifying the scope of use, authorship expectations, and data security requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriele Bellio, MD contact
Gary A Bass, MD, PhD study director
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
An observational study of Large Bowel Obstruction, run by European Society for Trauma and Emergency Surgery.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo M Cimino, MD (+393928811420, cimino.matteo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day morbidity (time frame: From hospital admission date or date of surgery (whichever is later) to 30 days later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.