Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000799550
Ethics application status
Approved
Date submitted
29/05/2015
Date registered
31/07/2015
Date last updated
7/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
DIVIT D - A prospective study on predictors and risk factors for acute and recurrent diverticulitis.
Scientific title
A prospective observational study on predictors and risk factors for acute and recurrrent diverticulitis requiring hospital admission.
Secondary ID [1] 286833 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diverticulitis 295218 0
Condition category
Condition code
Oral and Gastrointestinal 295465 295465 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Acute and recurrent diverticulitis, follow up for 24 months
Intervention code [1] 291994 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295193 0
Identify the risk factors associated with clinically significant diverticulitis requiring hospital admission.

Outcomes will be assessed reviewing laboratory results, patient medical history and demographics and patient completed questionnaire which was specifically designed for the trial.
Timepoint [1] 295193 0
2 years
Secondary outcome [1] 315012 0
Identify the proportion of young diverticulitis (less than 45 years old, but older than 18 years).

Outcomes will be assessed reviewing laboratory results, patient medical history and demographics and patient completed questionnaire which was specifically designed for the trial.
Timepoint [1] 315012 0
1 year observation
Secondary outcome [2] 315175 0
Identify any potential predictors of severe disease at index presentation and the need for early surgical intervention.

Outcomes will be assessed reviewing laboratory results, patient medical history and demographics and patient completed questionnaire which was specifically designed for the trial.
Timepoint [2] 315175 0
1 year observation
Secondary outcome [3] 315176 0
Identify the predictors of recurrent diverticulitis in this subgroup of patients.

Outcomes will be assessed reviewing laboratory results, patient medical history and demographics and patient completed questionnaire which was specifically designed for the trial.
Timepoint [3] 315176 0
1 year observation

Eligibility
Key inclusion criteria
Patients diagnosed diverticulitis over the age of 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Younger than 18 years of age

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2015
Actual
8/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3855 0
Gold Coast Hospital - Southport

Funding & Sponsors
Funding source category [1] 291382 0
Self funded/Unfunded
Name [1] 291382 0
Nil
Country [1] 291382 0
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Boulevard,
SOUTHPORT QLD 4215
Country
Australia
Secondary sponsor category [1] 290057 0
None
Name [1] 290057 0
Address [1] 290057 0
Country [1] 290057 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292938 0
Gold Coast University Hospital Human Research Ethics Committee
Ethics committee address [1] 292938 0
1 Hospital Boulevard,
SOUTHPORT QLD 4215
Ethics committee country [1] 292938 0
Australia
Date submitted for ethics approval [1] 292938 0
Approval date [1] 292938 0
17/03/2015
Ethics approval number [1] 292938 0
HREC/15/QGC/9

Summary
Brief summary
The DIVIT study is a prospective, observational study of hospitalised patients that have been diagnosed diverticulitis and diverticular disease. We will plan to identify those admitted to the Gold Coast and Robina Hospitals with the condition, and following them through their admission and discharge.

In Liaison with the Acute Surgical and Gastroenterology teams at the Gold Coast Hospital will enable the Research team to identify potential candidates. We will also monitor the computer tomography (CT) scans performed at the Gold Hospital health service for diagnosis of diverticulitis that are related to presentation. We will follow their progress with use of the electronic medical records (eMR).

Information about the study as well as a questionnaire looking at particular clinical factors will be given to the patients who have consented for the study.

As part of standard clinical care, patients will undergo blood tests, stool tests, imaging and endoscopy. These are what is comprised of standard treatment for acute diverticulitis. There is no alteration in their clinical care.

We will then analyse the collected data to determine any predictors for severe disease/ recurrent disease as stated in our aims. The data will be kept for 5 years, and at the end, will be deleted and consent forms will be destroyed.

We hope to capture a sample size of around 150-200 patients over the 2 year period

The purpose of the research is to identify and better understand the factors that cause diverticulitis, and distinguish between people who are more likely to develop the disease early in life and also get frequent attacks. This could have implications in aggressive approach or more conservative approach to management of acute and recurrent diverticulitis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57698 0
Dr Aiden Lyon
Address 57698 0
Gold Coast University Hospital
1 Hospital Boulevard,
SOUTHPORT QLD 4215
Country 57698 0
Australia
Phone 57698 0
+61 421985670
Fax 57698 0
Email 57698 0
[email protected]
Contact person for public queries
Name 57699 0
Dr Aiden Lyon
Address 57699 0
Gold Coast University Hospital
1 Hospital Boulevard,
SOUTHPORT QLD 4215
Country 57699 0
Australia
Phone 57699 0
+61 421 985 670
Fax 57699 0
Email 57699 0
[email protected]
Contact person for scientific queries
Name 57700 0
Dr Aiden Lyon
Address 57700 0
Gold Coast University Hospital
1 Hospital Boulevard,
SOUTHPORT QLD 4215
Country 57700 0
Australia
Phone 57700 0
+61 421 985 670
Fax 57700 0
Email 57700 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.