SnapSBO - Small Bowel Obstruction Snapshot Audit

Small Bowel Obstruction Clinical Trial

— SnapSBO  

Official title:

SnapSBO - An International Non-randomized Time-bound Prospective Observational Cohort Study Addressing the Epidemiology and Management of Small Bowel Obstruction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05843097
• Other study ID #: ESTESSnapSBO202324
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2023
• Source: European Society for Trauma and Emergency Surgery
• Contact: Isidro Martínez Casas, MD PhD
• Phone: + 34 608412421
• Email: isidromartinez[@]me.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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:

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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Obstruction

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocio	Sevilla	Andalucia

Sponsors (1)

Lead Sponsor	Collaborator
European Society for Trauma and Emergency Surgery

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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

Outcome

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