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

Sponsor

Northwell Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT05832242

Collaborator

(none)

4,000

Enrollment

Location

Anticipated Duration (Months)

166.6

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Diverticulitis	Other: Ultrasound

Study Design

Study Type:

Observational

Anticipated 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 :

Feb 28, 2023

Anticipated Primary Completion Date :

Feb 28, 2025

Anticipated Study Completion Date :

Feb 28, 2025

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

Simple Diverticulitis [48 hours]
Computed tomography scan showing isolated inflammation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	North Shore University Hospital	Manhasset	New York	United States	11030

Sponsors and Collaborators

Northwell Health

Investigators

Principal Investigator: Allison Cohen, MD, Northwell Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Northwell Health

ClinicalTrials.gov Identifier:

NCT05832242

Other Study ID Numbers:

22-0649

First Posted:

Apr 27, 2023

Last Update Posted:

Apr 27, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diverticulitis

Emergencies

Study Results

No Results Posted as of Apr 27, 2023