Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001125213
Ethics application status
Approved
Date submitted
6/02/2018
Date registered
9/07/2018
Date last updated
12/10/2021
Date data sharing statement initially provided
12/10/2021
Date results information initially provided
12/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Diverticulitis Outpatient Treatment Trial
Scientific title
Comparison of two methods of community-based antibiotic administration for treatment of patients with Diverticulitis in the community: The Diverticulitis Outpatient Treatment Trial
Secondary ID [1] 293975 0
Nil
Universal Trial Number (UTN)
U1111-1209-0435
Trial acronym
The DOT Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diverticulitis 306487 0
Condition category
Condition code
Oral and Gastrointestinal 305586 305586 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 305842 305842 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment of patients as outpatients under the care of the Hospital in the Home (HITH) team. Groups will be treated in one of two treatment arms, either with intravenous antibiotics or oral antibiotics.

IV antibiotics: Ceftriaxone 1g once daily, Metronidazole 500mg twice daily. (Three days total)
Oral antibiotics: Augmenting Du Forte 875mg/125mg twice daily. (Five days total).

Visits by HITH team members to ensure compliance.
Intervention code [1] 300247 0
Treatment: Other
Comparator / control treatment
Patients will be treated at home with the HITH team with either intravenous antibiotics or oral antibiotics. The reference group will be the IV antibiotic group.
Control group
Active

Outcomes
Primary outcome [1] 304707 0
Time to resumption of pre-morbid function. This will be assessed by a study specific questionnaire provided to the study participants that will be returned to the study coordinators during the first follow-up appointment.
Timepoint [1] 304707 0
Two weeks post commencement of intervention.
Secondary outcome [1] 342895 0
Re-presentation to hospital: study coordinators will be notified when a patient represents to ED and will be assessed as to whether they have represented due to their diverticulitis or other reasons. The re-presentation rate will assess the safety/efficacy of treating patients in the community with HITH versus as inpatients in hospital.
Timepoint [1] 342895 0
Two weeks post commencement of intervention.
Secondary outcome [2] 349160 0
Biochemical markers: assessed via laboratory testing. Blood samples will be collected by the HITH team during their visits. Key tests include a patients white cell count and CRP.
Timepoint [2] 349160 0
Two weeks post commencement of intervention.
Secondary outcome [3] 349161 0
Pain scores. Patients will be recording daily pain scores. Data will be collected via patient diaries and questionnaires.
Timepoint [3] 349161 0
Two weeks post commencement of intervention.
Secondary outcome [4] 349162 0
Patient satisfaction. Patients will be asked how satisfied they were with their treatment. Data will be collected via patient diaries and questionnaires.
Timepoint [4] 349162 0
Two weeks post commencement of intervention.
Secondary outcome [5] 349163 0
Time to return to normal diet/bowel habit. Data will be collected via patient diaries and questionnaires.
Timepoint [5] 349163 0
Two weeks post commencement of intervention.

Eligibility
Key inclusion criteria
CT proven uncomplicated acute diverticulitis.
Observation for two hours without deterioration.
Eligible for HITH.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active co-mobidities (i.e. Diabetes, Heart failure, Kidney failure).
Lives alone/poor social supports.
Clinical deterioration in first two hours of observation.
Unwilling to be treated at home with HITH.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be performed on the data collected to determine if outpatient management via HITH of uncomplicated acute diverticular disease is as safe, effective and results in higher patient satisfaction than current inpatient management.

A cost comparison will also be performed looking at the average cost per day and the average cost per admission between participants in the inpatient treatment group and the HITH treatment group.

This statistical analysis will involve the calculation of simple percentages comparing the outcomes obtained between the two groups with t-test analysis. An independent statistician will be recruited to assist in data analysing and statistical analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/07/2018
Actual
20/07/2018
Date of last participant enrolment
Anticipated
1/07/2020
Actual
1/07/2020
Date of last data collection
Anticipated
1/11/2020
Actual
1/11/2020
Sample size
Target
120
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9958 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 18789 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 298608 0
Hospital
Name [1] 298608 0
Dept of Surgery - Barwon Health
Country [1] 298608 0
Australia
Primary sponsor type
Hospital
Name
Dept of Surgery - Barwon Health
Address
Ryrie St & Bellerine St, Geelong VIC 3220
Country
Australia
Secondary sponsor category [1] 297765 0
None
Name [1] 297765 0
Address [1] 297765 0
Country [1] 297765 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299567 0
Barwon Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 299567 0
Ryrie St & Bellerine St, Geelong VIC 3220
Ethics committee country [1] 299567 0
Australia
Date submitted for ethics approval [1] 299567 0
06/02/2018
Approval date [1] 299567 0
28/02/2018
Ethics approval number [1] 299567 0
16/222

Summary
Brief summary
Aim: To determine if outpatient management (via Hospital in the Home [HITH]) of uncomplicated acute diverticular disease is as safe and effective.

Research Design: Patients who present to University Hospital Geelong Emergency Department diagnosed with acute uncomplicated diverticulitis with be randomised into either an intravenous antibiotics group or oral antibiotic group. Both groups will be treated as outpatients with the Hospital in the Home team.

Primary Endpoint: Time to resumption of normal activities of daily living.
Secondary Endpoints: Pain, Diet, Bowel habit, Patient satisfaction, Biochemical markers, Cost comparison.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80862 0
Dr Sam McClintock
Address 80862 0
Dept of Surgery, Barwon Health
Ryrie St & Bellerine St, Geelong VIC 3220
Country 80862 0
Australia
Phone 80862 0
+61 3 42150000
Fax 80862 0
Email 80862 0
[email protected]
Contact person for public queries
Name 80863 0
Dr Sam McClintock
Address 80863 0
Dept of Surgery, Barwon Health
Ryrie St & Bellerine St, Geelong VIC 3220
Country 80863 0
Australia
Phone 80863 0
+61 3 42150000
Fax 80863 0
Email 80863 0
[email protected]
Contact person for scientific queries
Name 80864 0
Dr Sam McClintock
Address 80864 0
Dept of Surgery, Barwon Health
Ryrie St & Bellerine St, Geelong VIC 3220
Country 80864 0
Australia
Phone 80864 0
+61 3 42150000
Fax 80864 0
Email 80864 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13532Study protocol  [email protected]
13533Informed consent form  [email protected]
13534Ethical approval  [email protected]



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.