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Developing a Decision Tool for Diverticulitis in the Emergency Department Using Ultrasound

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05832242
Recruitment Status : Recruiting
First Posted : April 27, 2023
Last Update Posted : April 27, 2023
Sponsor:
Information provided by (Responsible Party):
Northwell Health

Study Description
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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

Condition or disease Intervention/treatment
Diverticulitis Other: Ultrasound

Study Design
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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developing a Decision Tool for Diverticulitis in the Emergency Department Using Ultrasound
Actual Study Start Date : February 28, 2023
Estimated Primary Completion Date : February 28, 2025
Estimated Study Completion Date : February 28, 2025

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Simple Diverticulitis
Computed tomograpy scan showing isolated inflammation
 Other: Ultrasound
Point-of-care ultrasound in the emergency department
Complicated Diverticulitis
Computed tomograpy scan evidence of diverticulitis with either an associated abscess, fistula, obstruction, bleeding, phlegmon or perforation.
 Other: Ultrasound
Point-of-care ultrasound in the emergency department


Outcome Measures
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Primary Outcome Measures :
  1. Simple Diverticulitis [ Time Frame: 48 hours ]
    Computed tomography scan showing isolated inflammation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult emergency department patients suspected of having diverticulitis.
Criteria

Inclusion Criteria:

  • Emergency department patient
  • Provider suspicion of diverticulitis
  • CT scan ordered

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05832242


Contacts
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Contact: Timmy Li, PhD 5162403933 tli2@northwell.edu

Locations
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United States, New York
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Timmy Li, PhD    516-240-3933    tli2@northwell.edu   
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Allison Cohen, MD Northwell Health
More Information
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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT05832242    
Other Study ID Numbers: 22-0649
First Posted: April 27, 2023    Key Record Dates
Last Update Posted: April 27, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diverticulitis
Emergencies
Disease Attributes
Pathologic Processes
 Diverticular Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases