NCT04043988

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
718

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

3.4 years

First QC Date

August 1, 2019

Last Update Submit

May 1, 2023

Conditions

Diverticulitis

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olive View-UCLA Medical Center

Sylmar, California, 93142, United States

Location

MeSH Terms

Conditions

Diverticulitis

Condition Hierarchy (Ancestors)

Diverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 1, 2019

First Posted

August 2, 2019

Study Start

April 18, 2019

Primary Completion

August 30, 2022

Study Completion

April 30, 2023

Last Updated

May 3, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)