Clinical trial NCT05843097: SnapSBO - Small Bowel Obstruction Snapshot Audit
Official title: SnapSBO - An International Non-randomized Time-bound Prospective Observational Cohort Study Addressing the Epidemiology and Management of Small Bowel Obstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Bowel Obstruction
Keywords: diagnosis
management
guidelines
outcomes
Lead sponsor: European Society for Trauma and Emergency Surgery
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 1900
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (≥16 years of age) admitted for mechanical small bowel obstruction.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥16 years of age) admitted for mechanical small bowel obstruction. Example etiologies which should be included:

  1. Adhesions.
  2. Hernias with bowel compromise (incisional/parastomal, ventral, inguinal, femoral, obturator, internal).
  3. Malignancy (primary: lymphoma, carcinoid, GIST, adenocarcinoma/metastatic disease: colon, ovarian, gastric, pancreatic, melanoma and others).
  4. Enteroliths/gallstones/bezoars/foreign bodies
  5. Radiation.
  6. Inflammation (Crohn's disease, mesenteric adenitis, appendicitis, diverticulitis, tuberculosis, actinomycosis, ascariasis).
  7. Congenital (malrotation, duplication cysts).
  8. Trauma (hematomas, ischemic strictures).

Exclusion Criteria:

* Functional small bowel obstruction (dysmotility or adynamic ileus secondary to abdominal operations, peritonitis, trauma or medications).

Primary outcomes:
measure: Incidence of Small Bowel Obstruction, by etiology
timeFrame: 6 months
measure: Time to Surgical Treatment of Small Bowel Obstruction vs Outcomes
timeFrame: 6 months
Secondary outcomes:
measure: Complications related to operative or non-operative management of small bowel obstruction
timeFrame: 6 months from hospital admission
measure: Adherence to evidence-based guidelines vs outcomes
timeFrame: 6 months from hospital admission
measure: Patient-related Outcome Metrics for Surgical vs Non-operative management
timeFrame: At first post-discharge clinic visit, anticipated within 6 months of admission
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Andalucia
Study officials:
affiliation: Hospital Universitario Virgen del Rocio
name: Isidro Martínez Casas, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bass GA, Kaplan LJ, Ryan EJ, Cao Y, Lane-Fall M, Duffy CC, Vail EA, Mohseni S. The snapshot audit methodology: design, implementation and analysis of prospective observational cohort studies in surgery. Eur J Trauma Emerg Surg. 2023 Feb;49(1):5-15. doi: 10.1007/s00068-022-02045-3. Epub 2022 Jul 15.