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Management of Diverticulitis in the Emergency Department

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ClinicalTrials.gov Identifier: NCT04043988
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : September 18, 2020
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
David A. Talan, Olive View-UCLA Education & Research Institute

Tracking Information
First Submitted Date August 1, 2019
First Posted Date August 2, 2019
Last Update Posted Date September 18, 2020
Actual Study Start Date April 18, 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 2, 2019)
  • Rates of hospital admission [ Time Frame: Day 1 ]
    Rates of hospital admission from the emergency department among patients being treated for acute diverticulitis will be determined. In addition, factors associated with hospital admission will be examined.
  • Rate of Imaging [ Time Frame: Day 1 ]
    The rate of imaging performed in the emergency department among patients treated for acute diverticulitis will be determined. Factors associated with imaging will also be examined.
Original Primary Outcome Measures
 (submitted: August 1, 2019)
  • Hospital admission [ Time Frame: Day 1 ]
    Admission to Hospital
  • Imaging [ Time Frame: Day 1 ]
    Imaging received in emergency department
Change History
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 Management of Diverticulitis in the Emergency Department
Official Title Management of Diverticulitis in the Emergency Department
Brief Summary This study aims to describe current treatment practices in the US for managing acute uncomplicated diverticulitis. In addition, we will identify clinical factors associated with the decision to discharge versus hospitalize patients with uncomplicated diverticulitis with the goal of informing clinical decision-making and providing a foundation for diagnostic algorithms to guide clinical practice.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients presenting to the emergency departments at EMERGEncy ID NET sites will be screened for study eligibility by study coordinators or treating clinicians.
Condition Diverticulitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
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: August 1, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Emergency department presumptive or confirmed final diagnosis of acute diverticulitis
  • Verbal or written consent provided in English (or Spanish depending on study site)

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Anusha Krishnadasan, PhD 747-210-3107 idnet@ucla.edu
Contact: David Talan, MD 747-210-3107 dtalan@ucla.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04043988
Other Study ID Numbers 1396802
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: No
Responsible Party David A. Talan, Olive View-UCLA Education & Research Institute
Study Sponsor Olive View-UCLA Education & Research Institute
Collaborators Centers for Disease Control and Prevention
Investigators Not Provided
PRS Account Olive View-UCLA Education & Research Institute
Verification Date September 2020