Small Bowel Obstruction Clinical Trial
— SnapSBOOfficial 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.
Status | Not yet recruiting |
Enrollment | 250 |
Est. completion date | September 1, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Virgen del Rocio | Sevilla | Andalucia |
Lead Sponsor | Collaborator |
---|---|
European Society for Trauma and Emergency Surgery |
Spain,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 6 months | |
Primary | Time to Surgical Treatment of Small Bowel Obstruction vs Outcomes | Time (hours) from hospital admission to Surgical Treatment of Small Bowel Obstruction vs Outcomes | 6 months | |
Secondary | 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 | 6 months from hospital admission | |
Secondary | 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,%) | 6 months from hospital admission | |
Secondary | 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). | At first post-discharge clinic visit, anticipated within 6 months of admission |
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