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

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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

Tracking Information
First Submitted Date March 15, 2023
First Posted Date April 27, 2023
Last Update Posted Date April 27, 2023
Actual Study Start Date February 28, 2023
Estimated Primary Completion Date February 28, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 14, 2023)		 Simple Diverticulitis [ Time Frame: 48 hours ]
Computed tomography scan showing isolated inflammation
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Developing a Decision Tool for Diverticulitis in the Emergency Department Using Ultrasound
Official Title Developing a Decision Tool for Diverticulitis in the Emergency Department Using Ultrasound
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult emergency department patients suspected of having diverticulitis.
Condition Diverticulitis
Intervention Other: Ultrasound
Point-of-care ultrasound in the emergency department
Study Groups/Cohorts
  • Simple Diverticulitis
    Computed tomograpy scan showing isolated inflammation
    Intervention: Other: Ultrasound
  • Complicated Diverticulitis
    Computed tomograpy scan evidence of diverticulitis with either an associated abscess, fistula, obstruction, bleeding, phlegmon or perforation.
    Intervention: Other: Ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 14, 2023)		 4000
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2025
Estimated Primary Completion Date February 28, 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Timmy Li, PhD 5162403933 tli2@northwell.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05832242
Other Study ID Numbers 22-0649
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Northwell Health
Original Responsible Party Same as current
Current Study Sponsor Northwell Health
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Allison Cohen, MD Northwell Health
PRS Account Northwell Health
Verification Date April 2023