SnapSBO - Small Bowel Obstruction Snapshot Audit

NCT ID: NCT05843097

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-09-01

Brief Summary

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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

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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

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Small Bowel Obstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Society for Trauma and Emergency Surgery

OTHER

Sponsor Role lead

Responsible Party

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Isidro Martinez Casas, MD PhD

Chair, SnapSBO Steering Group

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isidro Martínez Casas, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen del Rocio

Locations

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Hospital Universitario Virgen del Rocio

Seville, Andalusia, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 35840703 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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ESTESSnapSBO202324

Identifier Type: -

Identifier Source: org_study_id

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