An observational study in Small Bowel Obstruction, sponsored by European Society for Trauma and Emergency Surgery. Completed at 1 site in Spain. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by European Society for Trauma and Emergency Surgery · Observational
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.
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:
Methods for identifying patients
Multiple methods may be used according to local circumstances/staffing:
European Society for Trauma and Emergency Surgery is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (≥16 years of age) admitted for mechanical small bowel obstruction.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adult patients (≥16 years of age) admitted for mechanical small bowel obstruction. Example etiologies which should be included:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Time frame: 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
Time frame: 6 months
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
Time frame: 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,%)
Time frame: 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).
Time frame: At first post-discharge clinic visit, anticipated within 6 months of admission
Plan to share: 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).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: After study main conclusions are published
Access criteria: Being one of study participating centers investigators
Ran from Nov 2023 to primary completion in Sep 2024, 10 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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European Society for Trauma and Emergency Surgery