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Trial registered on ANZCTR


Registration number
ACTRN12616001378415
Ethics application status
Approved
Date submitted
12/09/2016
Date registered
5/10/2016
Date last updated
19/06/2019
Date data sharing statement initially provided
19/06/2019
Date results information initially provided
19/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Dietary management of uncomplicated diverticulitis: what is the effect of inpatient dietary restriction and discharge diet prescription on length of stay, recurrence and patient outcomes in patients admitted to an acute-care hospital in South-East Queensland, Australia?
Scientific title
Conservative management of uncomplicated diverticulitis: what is the effect of inpatient dietary restriction and discharge diet prescription on length of stay, recurrence and patient outcomes in patients admitted to an acute-care hospital in South-East Queensland, Australia?
Secondary ID [1] 290120 0
None
Universal Trial Number (UTN)
U1111-1187-4296
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uncomplicated Diverticulitis 300223 0
Condition category
Condition code
Oral and Gastrointestinal 300100 300100 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
Description of intervention(s) / exposure
Acute, uncomplicated diverticulitis is a gastrointestinal disorder for which dietary management guidelines exist, but are based on inconsistent, poor quality evidence. Patients admitted to the surgical ward between January 2017 and March 2019 with acute, uncomplicated diverticulitis, at an acute care hospital in South-east Queensland will be observed from admission to 6-months post discharge.

Usual practice will be observed, where dietary prescription will be given at the clinical discretion of the treating gastroenterologist and dietary advice will be provided accordingly by dietitians external to the project. Regular treatment will be observed and no intervention will be applied by researchers.
Observations will be made and statistical analysis will be carried out to determine whether differences in patient outcomes exist depending on:
1). The diet prescription they receive during admission (restricted [nil by mouth, clear fluid or free fluid hospital foodservice diet codes for the first 48hours post admission] or liberalised [soft, low fibre or full hospital foodservice diet codes for the first 48hours post admission]); and
2). The dietary fibre intake post discharge (high fibre diet [meeting or exceeding RDI of 30g for men and 25g for women] or standard diet [dietary fibre intake <RDI).
Intervention code [1] 295870 0
Not applicable
Comparator / control treatment
Control groups will be that receiving usual care:
1). Restricted inpatient diet
2). Standard dietary fibre intake post discharge
Control group
Active

Outcomes
Primary outcome [1] 299581 0
readmission to hospital using data linkage to hospital records
Timepoint [1] 299581 0
30 days and 6 months post initial discharge
Primary outcome [2] 299582 0
Hospital readmission length of stay using data linkage to hospital records
Timepoint [2] 299582 0
30 days post initial discharge
Primary outcome [3] 299583 0
Gastrointestinal symptoms as determined by interview with participant
Timepoint [3] 299583 0
One assessment within 24-48 hours post admission and at 30 days post initial discharge
Secondary outcome [1] 327611 0
Patient Satisfaction using the Acute Care Hospital Foodservice Patient Satisfaction Questionnaire (ACHFPSQ)
Timepoint [1] 327611 0
At patient discharge

Eligibility
Key inclusion criteria
Adult inpatients (18 years old and above) at Robina Hospital, Queensland, admitted to the surgical ward with a diagnosis of uncomplicated diverticulitis (Hinchey 0-Ib) diagnosed via CT scan and managed with conservative treatment (no surgery performed or drainage placed). A translator will be sought for non-English speaking patients.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they are pregnant; unable to give informed consent; do not have CT-proven diagnosis; or are diagnosed to have complicated diverticulitis (Hinchey II and above).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
There is estimated to be 84- 140 participants as predicted from current trends at at the hospital sites showing 3-5 admissions of eligible cases per week.

Statistical analysis will be completed using SPSS software. All data will be assessed for normality (Shapiro-Wilk test) or homogeneity of variance for continuous variables (Levene's Test). Mean +/- SD/SE for normal variables and median (inter-quartile range) for skewed variables will be used to report patient characteristics.

Liberalised Diet Group versus Restrictive Diet Group; Low Dietary Fibre Diet Group versus Standard Diet Group; and pairing of inpatient and discharge diet prescriptions will be tested for 1). association with hospital readmission and bristol stool chart type via binomial logistic regression adjusting for potentially confounding variables. 2). association with 30 day and 6 month hospital readmission length of stay and GSRS score via multiple linear regression adjusting for potentially confounding variables.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6646 0
Robina Hospital - Robina
Recruitment hospital [2] 11406 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 14270 0
4226 - Robina
Recruitment postcode(s) [2] 23311 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 294499 0
University
Name [1] 294499 0
Bond University
Address [1] 294499 0
14 University Drive, Robina, QLD, 4226
Country [1] 294499 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Drive, Robina, QLD, 4226
Country
Australia
Secondary sponsor category [1] 293363 0
None
Name [1] 293363 0
Address [1] 293363 0
Country [1] 293363 0
Other collaborator category [1] 279222 0
Hospital
Name [1] 279222 0
Robina Hospital
Address [1] 279222 0
2 Bayberry Lane, Robina, QLD, 4226
Country [1] 279222 0
Australia
Other collaborator category [2] 280233 0
Hospital
Name [2] 280233 0
Gold Coast University Hospital
Address [2] 280233 0
1 Hospital Blvd, Southport QLD 4215, Australia
Country [2] 280233 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295933 0
Gold Coast Hospital and Health Service (GCHHS) Human Research Ethics Committee (HREC)
Ethics committee address [1] 295933 0
Research and Ethics Communications
Level 2, Block E,
GoldCoast University Hospital
1 Hospital Boulevard, Southport, Qld 4215
Ethics committee country [1] 295933 0
Australia
Date submitted for ethics approval [1] 295933 0
23/09/2016
Approval date [1] 295933 0
16/12/2016
Ethics approval number [1] 295933 0
HREC/16/QGC/282
Ethics committee name [2] 300930 0
Bond University Human Research Ethics Committee
Ethics committee address [2] 300930 0
Research Services,
Bond University
University Drive
Robina
Queensland 4226
Ethics committee country [2] 300930 0
Australia
Date submitted for ethics approval [2] 300930 0
06/10/2016
Approval date [2] 300930 0
18/10/2016
Ethics approval number [2] 300930 0
15866

Summary
Brief summary
It is known that modern Australian society is trending towards an ageing population combined with a poor intake of foods rich in dietary fibre such as wholegrains, fruits and vegetables. Therefore, as diverticulitis is highly prevalent in older adults, it is predicted to become even more prevalent in the future. In addition, it is also suggested that the disease is now occurring more commonly in younger ages. Furthermore, the evidence that is in existence to support current dietary managements is inconsistent, of poor quality and lacking in Australia. Therefore, observational research is warranted to explore the impact of current clinical practice in Australia upon patient and healthcare related outcomes.

In adults admitted to an acute-care hospital with acute, uncomplicated diverticulitis in South-East Queensland, Australia, it is hypothesised that:
1). Participants who are prescribed and adhere to liberalised diets during hospital admission have less healthcare use and no difference in gastrointestinal symptom scores compared to those prescribed restricted (fluid only) diets. 2). Participants who follow a high fibre diet following discharge have lower healthcare use and gastrointestinal symptom scores than those following a standard diet.

A Low or Negligible Risk (LNR) research application for ethical approval has been submitted as this study intends to be of low risk to research participants as the likelihood and severity of any risks to the patient is low. Possible risks include using vulnerable, sick patients as the study population as well as fatigue, inconvenience or discomfort of talking about personal issues. To minimise risks, high risk patients will be excluded from the study, patient involvement will be as minimal as possible by accessing medical records and eligible participants will be asked to provide informed consent. Data will also be gathered and kept in a de-identifiable format where possible with identifiable data stored in password protected electronic files or a locked filing cabinet. Researchers will be the only ones to have access to this information.

The intended outcomes of this study include a greater understanding of acute uncomplicated diverticulitis. Future research that can stem from findings of this study, may then help to formulate best practice guidelines for the dietary management of acute, uncomplicated diverticulitis as such is currently non-existent. This would help to achieve cohesion across treating doctors and dietitians. It is believed that theses outcomes and associated potential benefits that this study can provide will far outweigh the possible minimal risks.
Trial website
Trial related presentations / publications
Poster Presentation: 43rd Annual Scientific Meeting of the Australasian Society for Parenteral and Enteral Nutrition (November 2017 – Gold Coast): Dietary fibre modification with or without antibiotics in the prevention of diverticulitis in adults with diverticular disease. Presented by Skye Marshall.
Poster Presentation: 43rd Annual Scientific Meeting of the Australasian Society for Parenteral and Enteral Nutrition (November 2017 – Gold Coast): Evidence for dietary fibre modification for the prevention of acute, uncomplicated diverticulitis: a systematic literature review. Presented by Skye Marshall.
Oral presentation: Gold Coast Health Research Week (November 2017 – Gold Coast): Influence of inpatient dietary restriction on acute uncomplicated diverticulitis: A pilot observational study. Presented by Megan Crichton.
Oral presentation: Gold Coast Health Research Week (November 2017 – Gold Coast): Evidence for dietary fibre modification for the prevention of diverticulitis: a systematic literature review. Presented by Megan Crichton.
Oral Presentation: Dietitians Association of Australia 2017: The 34th National Conference (May 2017 – Hobart): The effect of dietary fibre modification and bowel rest on patient and health care outcomes in patients admitted to hospital with acute, uncomplicated diverticulitis: A systematic literature review and meta-analysis. Presented by Camilla Dahl.
Publication: Dahl C, Crichton M, Jenkins J, Nucera R, Mahoney S, Marshall S. Dietary fibre modification in the recovery and prevention of reoccurrence of acute, uncomplicated diverticulitis: A systematic review and meta-analysis. Nutrients. 2018;10:137.
Public notes

Contacts
Principal investigator
Name 68934 0
Mrs Romina Nucera
Address 68934 0
Robina Hospital
2 Bayberry Lane
Robina, Qld, 4226
Country 68934 0
Australia
Phone 68934 0
+61 (07) 5668 6000
Fax 68934 0
Email 68934 0
Romina.Nucera@health.qld.gov.au
Contact person for public queries
Name 68935 0
Mrs Yvonne Chen
Address 68935 0
Robina Hospital
2 Bayberry Lane
Robina, Qld, 4226
Country 68935 0
Australia
Phone 68935 0
+61 (07) 5668 6000
Fax 68935 0
Email 68935 0
Yvonne.Chen@health.qld.gov.au
Contact person for scientific queries
Name 68936 0
Dr Skye Marshall
Address 68936 0
Bond Institute of Health & Sport
2 Promethean Way
Robina, Qld, 4226
Country 68936 0
Australia
Phone 68936 0
+61 7 559 55530
Fax 68936 0
Email 68936 0
skye_marshall@bond.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary