DiverticulitisNCT04043988
Management of Diverticulitis in the Emergency Department
An observational study of Diverticulitis, run by Olive View-UCLA Education & Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulitis
- How many people
- 718 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2019to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Olive View-UCLA Medical Center
Sylmar, California, 93142
About this study
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.
- Conditions
- Diverticulitis
- Medical subject headings
- Diverticulitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of hospital admission
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.
Measured: Day 1
Rate of Imaging
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start18 Apr 2019
- Primary completion30 Aug 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olive View-UCLA Education & Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, David A. Talan, Olive View-UCLA Education & Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043988
- Sponsor's protocol ID
- 1396802
- Status last verified
- May 2023
- First submitted
- 1 Aug 2019
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Diverticulitis in the Emergency Department
- ClinicalTrials.gov ID
- NCT04043988
- Acronym / sponsor ID
- 1396802
- Conditions
- Diverticulitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- Olive View-UCLA Education & Research InstituteUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticulitis, run by Olive View-UCLA Education & Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of hospital admission (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.