Management of Diverticulitis in the Emergency Department | NCT04043988

Studies
Management of Diverticulitis in the Emergency Department

NCT04043988

Sponsor

Olive View-UCLA Education & Research Institute

Status

Completed

Last Update Posted

May 3, 2023Actual

Enrollment

718Actual

Phase

Not provided

Conditions

Diverticulitis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 18, 2019Actual

Primary Completion Date

Aug 30, 2022Actual

Completion Date

Apr 30, 2023Actual

First Submitted Date

Aug 1, 2019

First Submission Date that Met QC Criteria

Aug 1, 2019

First Posted Date

Aug 2, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2023

Last Update Posted Date

May 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David A. Talan, Principal Investigator, Olive View-UCLA Education & Research InstitutePrincipal Investigator

Lead Sponsor

Olive View-UCLA Education & Research InstituteOTHER

Collaborators

Name	Class
Centers for Disease Control and Prevention	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

718Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Olive View-UCLA Medical Center		Sylmar	California	93142	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004238	Diverticulitis

Ancestor Terms

ID	Term
D000076385	Diverticular Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided