- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05843097
SnapSBO - Small Bowel Obstruction Snapshot Audit (SnapSBO)
SnapSBO - An International Non-randomized Time-bound Prospective Observational Cohort Study Addressing the Epidemiology and Management of Small Bowel Obstruction
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.
Study Overview
Status
Conditions
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:
- Daily review of emergency department (non-operative) and operating room lists.
- Daily review of team handover sheets / emergency admission lists / ward lists.
- Review of operating room logbooks.
- Use of electronic systems to flag any readmissions of patients identified and treated.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Isidro Martínez Casas, MD PhD
- Phone Number: + 34 608412421
- Email: isidromartinez@me.com
Study Contact Backup
- Name: Gary A Bass, MD PhD
- Email: gary.bass@pennmedicine.upenn.edu
Study Locations
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Andalucia
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Sevilla, Andalucia, Spain, 41013
- Hospital Universitario Virgen del Rocio
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Contact:
- Isidro Martínez Casas, MD, PhD
- Phone Number: +34 608412421
- Email: isidromartinez@me.com
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Contact:
- Isidro Martínez Casas, MD PhD
- Phone Number: 954104197
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Adult patients (≥16 years of age) admitted for mechanical small bowel obstruction. Example etiologies which should be included:
- Adhesions.
- Hernias with bowel compromise (incisional/parastomal, ventral, inguinal, femoral, obturator, internal).
- Malignancy (primary: lymphoma, carcinoid, GIST, adenocarcinoma/metastatic disease: colon, ovarian, gastric, pancreatic, melanoma and others).
- Enteroliths/gallstones/bezoars/foreign bodies
- Radiation.
- Inflammation (Crohn's disease, mesenteric adenitis, appendicitis, diverticulitis, tuberculosis, actinomycosis, ascariasis).
- Congenital (malrotation, duplication cysts).
- Trauma (hematomas, ischemic strictures).
Exclusion Criteria:
- Functional small bowel obstruction (dysmotility or adynamic ileus secondary to abdominal operations, peritonitis, trauma or medications).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Small Bowel Obstruction, by etiology
Time Frame: 6 months
|
This study aims to quantify (as an integer, n) the etiologies of small bowel obstruction (adhesions, hernias, malignancy and other causes)
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6 months
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Time to Surgical Treatment of Small Bowel Obstruction vs Outcomes
Time Frame: 6 months
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Time (hours) from hospital admission to Surgical Treatment of Small Bowel Obstruction vs Outcomes
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications related to operative or non-operative management of small bowel obstruction
Time Frame: 6 months from hospital admission
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Complications related to operative or non-operative management of small bowel obstruction (integer count n,%) - for example haemorrhage, wound infection, venous thromboembolism, anastomotic leak
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6 months from hospital admission
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Adherence to evidence-based guidelines vs outcomes
Time Frame: 6 months from hospital admission
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Adherence to evidence-based World Society of Emergency Surgery Bologna guideline 2020 recommendations (Table 5: available here https://wjes.biomedcentral.com/articles/10.1186/s13017-018-0185-2/tables/5)
vs outcomes (30-day post operative or hospital discharge survival (median days), length of hospital stay (median days), Complications related to operative or non-operative management of small bowel obstruction (integer count n,%) - for example haemorrhage, wound infection, venous thromboembolism, anastomotic leak (integer count n,%)
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6 months from hospital admission
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Patient-related Outcome Metrics for Surgical vs Non-operative management
Time Frame: At first post-discharge clinic visit, anticipated within 6 months of admission
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Patient-related Outcome Metrics for Surgical vs Non-operative management, using the PROdiGI (Patient Reported Outcome Measure for GastroIntestinal Recovery) qualitative quality-of-life assessment tool specifically designed for gastro-intestinal symptoms in adult patients undergoing major abdominal surgery for indications OR patients being treated for intestinal obstruction regardless of etiology.
Patients will be assisted in completing an anonymous survey where domains of gastrointestinal function are assessed using a 20-element Likert scales (with higher scores denoting worse perceived function) and a Visual Analog Scale 0-100 grading function from 0 (worst) to 100 (best).
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At first post-discharge clinic visit, anticipated within 6 months of admission
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Collaborators and Investigators
Investigators
- Principal Investigator: Isidro Martínez Casas, MD PhD, Hospital Universitario Virgen del Rocio
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESTESSnapSBO202324
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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