Small Bowel ObstructionSnapSBONCT05843097
SnapSBO - Small Bowel Obstruction Snapshot Audit
An observational study of Small Bowel Obstruction, run by European Society for Trauma and Emergency Surgery at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Small Bowel Obstruction
- How many people
- 1,900 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2023to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients (≥16 years of age) admitted for mechanical small bowel obstruction.
Who may be able to join
- 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.
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- Inflammation (Crohn's disease, mesenteric adenitis, appendicitis, diverticulitis, tuberculosis, actinomycosis, ascariasis).
- Congenital (malrotation, duplication cysts).
- Trauma (hematomas, ischemic strictures).
Who cannot join
- Functional small bowel obstruction (dysmotility or adynamic ileus secondary to abdominal operations, peritonitis, trauma or medications).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Small Bowel Obstruction
- Keywords
- diagnosis, management, guidelines, outcomes
- Medical subject headings
- Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Small Bowel Obstruction, by etiology
This study aims to quantify (as an integer, n) the etiologies of small bowel obstruction (adhesions, hernias, malignancy and other causes)
Measured: 6 months
Time to Surgical Treatment of Small Bowel Obstruction vs Outcomes
Time (hours) from hospital admission to Surgical Treatment of Small Bowel Obstruction vs Outcomes
Measured: 6 months
Secondary outcomes (3)
Complications related to operative or non-operative management of small bowel obstruction
Complications related to operative or non-operative management of small bowel obstruction (integer count n,%) - for example haemorrhage, wound infection, venous thromboembolism, anastomotic leak
Measured: 6 months from hospital admission
Adherence to evidence-based guidelines vs outcomes
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,%)
Measured: 6 months from hospital admission
Patient-related Outcome Metrics for Surgical vs Non-operative management
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).
Measured: At first post-discharge clinic visit, anticipated within 6 months of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Nov 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Bowel ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society for Trauma and Emergency Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isidro Martinez Casas, MD PhD, European Society for Trauma and Emergency Surgery
- Investigators
- Isidro Martínez Casas, MD PhD, Principal investigator, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843097
- Sponsor's protocol ID
- ESTESSnapSBO202324
- Acronym
- SnapSBO
- Status last verified
- Sep 2024
- First submitted
- 10 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The ESTES SnapAppy Group welcomes the use of these de-identified pooled data for further research that benefits patients. Requests can be submitted to the ESTES Research Committee. Release is subject to their approval and the appropriate safeguarding as determined by applicable legislation (GDPR and HIPAA).
Publications
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.
PubMed 35840703
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SnapSBO - An International Non-randomized Time-bound Prospective Observational Cohort Study Addressing the Epidemiology and Management of Small Bowel Obstruction
- ClinicalTrials.gov ID
- NCT05843097
- Acronym / sponsor ID
- SnapSBO / ESTESSnapSBO202324
- Conditions
- Small Bowel Obstruction
- Keywords
- diagnosis, management, guidelines, outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,900 participants (actual)
- Lead sponsor
- European Society for Trauma and Emergency SurgeryUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients (≥16 years of age) admitted for mechanical small bowel obstruction.
Key inclusion criteria (9 listed)
- Adult patients (≥16 years of age) admitted for mechanical small bowel obstruction. Example etiologies which should be included:
Key exclusion criteria (1 listed)
- Functional small bowel obstruction (dysmotility or adynamic ileus secondary to abdominal operations, peritonitis, trauma or medications).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Time to Surgical Treatment of Small Bowel Obstruction vs Outcomes
Time frame: 6 months
Time (hours) from hospital admission to Surgical Treatment of Small Bowel Obstruction vs Outcomes
3 secondary outcomes
Complications related to operative or non-operative management of small bowel obstruction
Time frame: 6 months from hospital admission
Adherence to evidence-based guidelines vs outcomes
Time frame: 6 months from hospital admission
Patient-related Outcome Metrics for Surgical vs Non-operative management
Time frame: At first post-discharge clinic visit, anticipated within 6 months of admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 35840703Bass 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.
- Individual participant dataSharing planned: Yes. The ESTES SnapAppy Group welcomes the use of these de-identified pooled data for further research that benefits patients. Requests can be submitted to the ESTES Research Committee. Release is subject to their approval and the appropriate safeguarding as determined by applicable legislation (GDPR and HIPAA).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isidro Martínez Casas, MD PhD principal investigator
Hospitales Universitarios Virgen del Rocío
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Bowel Obstruction, run by European Society for Trauma and Emergency Surgery at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Small Bowel Obstruction, by etiology (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05843097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.