Developing a Decision Tool for Diverticulitis in the Emergency Department Using Ultrasound
1 other identifier
observational
4,000
1 country
1
Brief Summary
The purpose of this study is to create a decision tool using ultrasound, patient history, and laboratory values to predict a diagnosis of complicated diverticulitis and whether the patient requires further imaging. The accuracy of the decision tool will be evaluated. This study will also assess the ability of ultrasound to diagnose complicated and simple diverticulitis, and the inter-provider reliability of ultrasound interpretation of diverticulitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2023
CompletedFirst Submitted
Initial submission to the registry
March 15, 2023
CompletedFirst Posted
Study publicly available on registry
April 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedApril 27, 2023
April 1, 2023
2 years
March 15, 2023
April 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Simple Diverticulitis
Computed tomography scan showing isolated inflammation
48 hours
Study Arms (2)
Simple Diverticulitis
Computed tomograpy scan showing isolated inflammation
Complicated Diverticulitis
Computed tomograpy scan evidence of diverticulitis with either an associated abscess, fistula, obstruction, bleeding, phlegmon or perforation.
Interventions
Point-of-care ultrasound in the emergency department
Eligibility Criteria
Adult emergency department patients suspected of having diverticulitis.
You may qualify if:
- Emergency department patient
- Provider suspicion of diverticulitis
- CT scan ordered
You may not qualify if:
- Pregnant patient
- Prisoner
- Non-English speaking
- Inability to provide informed consent
- Hemodynamically unstable as determined by provider
- Previous abdominal surgery within last 7 days
- Unable to lay flat for ultrasound exam
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
Study Sites (1)
North Shore University Hospital
Manhasset, New York, 11030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allison Cohen, MD
Northwell Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2023
First Posted
April 27, 2023
Study Start
February 28, 2023
Primary Completion
February 28, 2025
Study Completion
February 28, 2025
Last Updated
April 27, 2023
Record last verified: 2023-04