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

April 14, 2023 updated by: Northwell Health
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult emergency department patients suspected of having diverticulitis.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Simple Diverticulitis
Time Frame: 48 hours
Computed tomography scan showing isolated inflammation
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Allison Cohen, MD, Northwell Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Anticipated)

February 28, 2025

Study Completion (Anticipated)

February 28, 2025

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0649

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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