Large Bowel Obstruction
Conditions
Keywords
Large-bowel obstruction, stoma, colonic obstruction, bridge to surgery, snapshot audit, observational cohort
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.
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.
Interventions
None listed
Sponsors
European Society for Trauma and Emergency Surgery
Association of Surgeons of Great Britain and Ireland
European Society of Coloproctology
American Society of Colon and Rectal Surgeons
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30 day morbidity | 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
| Measure | Time frame | Description |
|---|---|---|
| 30 day mortality | 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. |
| Stoma creation | 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). |
| Stoma reversal | 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. |
| Length of hospital stay | 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. |
| 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). | 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). |
| Use of minimally invasive surgical approach | 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. |
| Number of participants with self expanding metallic stents. | From hospital day 0 (baseline) up to 90 days | Use of self expanding metallic stent before surgical resection in patients with colonic obstruction. |
| Unplanned readmission | From initial inpatient hospitalization (baseline) up to 90 days | Unplanned hospital readmission related to complications or sequelae of large-bowel obstruction or its management. |
| Patient-reported assessment of gastrointestinal recovery | 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. |
Contacts
CONTACTMatteo M Cimino, MD
CONTACTGabriele Bellio, MD
STUDY_DIRECTORGary A Bass, MD, PhD
University of Pennsylvania
Outcome results
None listed