Trials / Completed
CompletedNCT05843097
SnapSBO - Small Bowel Obstruction Snapshot Audit
SnapSBO - An International Non-randomized Time-bound Prospective Observational Cohort Study Addressing the Epidemiology and Management of Small Bowel Obstruction
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,900 (actual)
- Sponsor
- European Society for Trauma and Emergency Surgery · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
Small bowel obstruction (SBO) and its complications are frequently seen in patients admitted through the Emergency Departments of all acute care hospitals2. There is variation in the optimal use of imaging, the appropriate timing and duration of non-operative management attempts, anti-microbial therapies, and the criteria for surgical management, which results in heterogeneity in approaches and outcomes across international clinical centers. The expected number of SBO cases in most clinical centers is predictable, enabling a suitably-sized cohort of patients to be gathered in the snapshot audit. This 'ESTES snapshot audit' -a prospective observational cohort study- has a dual purpose. Firstly, as an epidemiological study, it aims to uncover the burden of disease. Secondly, it aims to demonstrate current strategies employed to diagnose and treat these patients. These twin aims will serve to provide a 'snapshot' of current practice, but will also be hypothesis-generating while providing a rich source of patient-level data to allow further analysis of the particular clinical questions.
Detailed description
Prospective audit of consecutive patients admitted in Emergency Department for mechanical small bowel obstruction over a 3-month period. The audit shall include unscheduled patient admissions from November 2023 until May 2024 as outlined in 'Key Study Dates'. As this is an observational cohort audit, no change to normal patient management is required. Primary Objective To explore differences in patients, management and outcomes across the entire cohort to identify areas of practice variability resulting in apparent differences in outcome warranting further study. The outcomes that the study will examine are: * Incidence of small bowel obstruction by etiology. * Differences in clinical presentation. * Diagnostic work-up. * Non-operative management strategies. * Time to surgery and outcomes. * Complications related to disease and/or therapies within 60 post-operative days. * Length of Emergency Department and Hospital stay. * Re-admission within 6 months for related conditions. Methods for identifying patients Multiple methods may be used according to local circumstances/staffing: 1. Daily review of emergency department (non-operative) and operating room lists. 2. Daily review of team handover sheets / emergency admission lists / ward lists. 3. Review of operating room logbooks. 4. Use of electronic systems to flag any readmissions of patients identified and treated.
Conditions
Timeline
- Start date
- 2023-11-01
- Primary completion
- 2024-09-01
- Completion
- 2024-09-01
- First posted
- 2023-05-06
- Last updated
- 2024-09-19
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT05843097. Inclusion in this directory is not an endorsement.