Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000002886
Ethics application status
Approved
Date submitted
24/09/2020
Date registered
7/01/2021
Date last updated
7/01/2021
Date data sharing statement initially provided
7/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preoperative exclusive enteral nutrition versus usual care in Crohn's disease
Scientific title
Randomised controlled trial of pre-surgical exclusive enteral nutrition versus usual care in patients with Crohn’s disease: a feasibility study
Secondary ID [1] 301245 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's disease 317821 0
Condition category
Condition code
Surgery 315879 315879 0 0
Other surgery
Oral and Gastrointestinal 315880 315880 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised one of three arms for six weeks prior to surgery - exclusive enteral nutrition or partial enteral nutrition with a Crohn's disease exclusion diet or usual care.
Exclusive enteral nutrition provides 100% of a person nutritional requirements and excludes of all other foods and fluids with the exception of water and black tea or coffee. Exclusive enteral nutrition and partial enteral nutrition (50% of nutritional requirements) with a ready to drink polymeric nutrition formula (e.g. Ensure Plus or Fortisip) will be used for six weeks prior to surgery. Dietary education on how to use exclusive enteral nutrition or partial enteral nutrition with an exclusion diet will be delivered by a New Zealand Registered Dietitian using video consultation and phone follow up and with using existing education resources.
The quantity of liquid nutrition drank by each participant will be calculated and monitored by the dietitian and individualised to each patient based on their weight and lifestyle using standard nutrition assessment tools.
Adherence to the two enteral nutrition treatments will be monitored by patients counting the number of cartons of remaining each week and reporting this on an electronic form or to the dietitian during 4 telephone follow up calls during the six week treatment. Patients will also be asked to self-report any deviations from enteral nutrition treatment protocols.
Intervention code [1] 318521 0
Treatment: Other
Comparator / control treatment
Usual care is defined as limited dietary education from a New Zealand registered dietitian. Dietary education may include written and oral information on a high protein high energy diet and/or texture modified diet if applicable using existing resources based on the patients current dietary intake. This education will be delivered in person by a New Zealand registered dietitian. Each patient in usual care will complete a questionnaire and have a telephone follow up with a registered dietitian 4 times in the six week prior to surgery. The dietitian will assess if patients are meeting their nutritional requirements from an oral diet and may/may not prescribe up to two oral nutritional supplements (e.g. Ensure Plus or Fortisip).
Control group
Active

Outcomes
Primary outcome [1] 325014 0
To determine whether it is feasible to recruit patients with Crohn’s disease undergoing gastrointestinal surgery in a single-blinded RCT to compare enteral nutrition treatments and standard care.
This will be assessed by calculating the recruitment rate (comparing the number of potentially eligible patients to the number of patients recruited) .
Timepoint [1] 325014 0
20 months after first participant enrolled
Primary outcome [2] 325526 0
To determine retention rate to the study intervention arms.
This will be assessed by calculating the number of patients enrolled in each arm of the study compared to the number who complete the intervention period.
Timepoint [2] 325526 0
20 months after enrolment of first participant.
Primary outcome [3] 326077 0
To determine whether it is feasible to collect the planned primary and secondary effectiveness objectives. This will be assessed by calculating the proportion of patients who completed each outcome at each of the three time points.
Timepoint [3] 326077 0
20 months after enrolment of first participant
Secondary outcome [1] 386584 0
Primary effectiveness objective:
30-day post-surgical complication rate using the Clavien Dindo classification.
Timepoint [1] 386584 0
30 days post-surgery
Secondary outcome [2] 386585 0
Intraoperative stoma formation
Timepoint [2] 386585 0
within 48 hours after surgery.
Secondary outcome [3] 386586 0
Feasibility outcomes of adherence to enteral nutrition treatments. Measured using count number of supplement cartons and self-reported consumption of disallowed foods and fluids.



.
Timepoint [3] 386586 0
Four times during the six week intervention period at weeks 1, 2, 4 and 5.
Secondary outcome [4] 388286 0
Hospital length of stay. Calculated from hospital records
Timepoint [4] 388286 0
Upon discharge from hospital after gastrointestinal surgery.
Secondary outcome [5] 388287 0
Mucosal damage before and after nutrition intervention. This will be measured by change in sMaRIA score calculated from a Magnetic Resonance enterography (MRE).
Timepoint [5] 388287 0
Calculated from a pre (within three months of enrolment in the study) and post intervention image (within the seven days prior to surgery date).
Secondary outcome [6] 388292 0
Change in food-related quality of life measured using validated FR-QOL-29 questionnaire.
Timepoint [6] 388292 0
Measured before and after the intervention and three months post surgery.
Secondary outcome [7] 388293 0
Quality of life measured using the validated questionnaire UK-IBDQ.
Timepoint [7] 388293 0
Baseline, pre-surgery and three months post-surgery
Secondary outcome [8] 388294 0
Disease activity measured using validated questionnaire the Harvey Bradshaw index
Timepoint [8] 388294 0
Baseline, pre-surgery and three months post-surgery.
Secondary outcome [9] 388295 0
Nutritional status measured by assessing weight (measured in kilograms), mid-arm muscle circumference (using tricep skin fold and mid arm circumference), handgrip strength (using a handgrip dynamometer), and body composition (using a bioelectrical impedance analyser).
Timepoint [9] 388295 0
Baseline, pre-surgery and three month post-surgery.
Secondary outcome [10] 388296 0
Gut inflammation measured using biomarker faecal calprotectin.
Timepoint [10] 388296 0
Baseline, pre-surgery and three months post-surgery.

Eligibility
Key inclusion criteria
Adults over 16 years old with diagnosed Crohn's disease who have consented to have elective gastrointestinal resection for the management of Crohn's disease.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with Crohn’s disease requiring emergency surgery or surgery within 6 weeks
Currently has a stoma – may affect study outcomes
Requires pre-operative parenteral nutrition. This patient group are unlikely to tolerate the
usual care intervention
Patients at high risk of malnutrition defined as BMI < 18.5 and greater than 10% body weight
loss in last 6 months – malnutrition independently affects surgical outcomes.
Patients who cannot attend the baseline and pre-surgical assessment appointments – this
would result in incomplete secondary outcomes data collection
Does not speak English

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised by a research dietitian at the individual level, stratified by the recruitment site using randomise random number generator with a 1:1 ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The feasibility study is not powered to find a difference between in intervention groups, thus no formal analysis of outcomes between the intervention groups will be conducted.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/10/2020
Date of last participant enrolment
Anticipated
31/03/2022
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
30
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 22921 0
New Zealand
State/province [1] 22921 0
Christchurch and Auckland

Funding & Sponsors
Funding source category [1] 305693 0
Government body
Name [1] 305693 0
Health Research Council
Country [1] 305693 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
2 Riccarton Avenue, Christchurch Central, Christchurch 8011
Country
New Zealand
Secondary sponsor category [1] 306106 0
None
Name [1] 306106 0
Address [1] 306106 0
Country [1] 306106 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305971 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 305971 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 305971 0
New Zealand
Date submitted for ethics approval [1] 305971 0
Approval date [1] 305971 0
18/08/2020
Ethics approval number [1] 305971 0
20/590

Summary
Brief summary
Many patients with Crohn’s disease, an inflammatory bowel disease, will require gastrointestinal surgery to remove diseased parts of their bowel during their lifetime. Malnutrition is common in patients with Crohn’s disease and is an independent risk factor of poor surgical outcomes. Retrospective and uncontrolled studies suggest that 4-6
weeks of exclusive enteral nutrition, a nutritional complete liquid diet, prior to surgery improves nutritional status, reduces gut inflammation and is associated with fewer intraoperative stomas, reduced hospital length of stay and less surgical complications. Currently, there are no prospective randomised controlled trials of exclusive enteral
nutrition in patients requiring elective surgery for Crohn’s disease. Significant healthcare savings, and patient quality of life improvements, could result from the use of preoperative exclusive enteral nutrition according to previous cost-benefit analyses. A feasibility randomised controlled trial is proposed to assess the validity of the trial interventions, methods and effectiveness outcomes in the management of Crohn’s disease.

Aim 1. To determine whether it is feasible to recruit and retain patients with Crohn’s disease undergoing gastrointestinal surgery in a randomised single-blinded study to compare exclusive enteral nutrition and standard care.

Aim 2: To determine whether it is feasible to collect the planned primary and secondary effectiveness objectives.

This is a multi-centre feasibility randomised controlled trial of preoperative exclusive enteral nutrition versus standard care in 20-25 patients aged 16+ years requiring elective gastrointestinal surgery for management of their Crohn’s disease. Patients will be recruited from Auckland City area and Christchurch City (including the public and private hospitals) and randomised 1:1, stratified by city, to receive either six weeks of exclusive enteral nutrition, partial enteral nutrition with an exclusion diet or standard care.
Trial website
Trial related presentations / publications
Public notes
Due to the nature of the study the participants and the research dietitian will not be blinded to treatment allocation after randomisation but the members of the clinical team, including the surgeon who will perform the surgery, will be blinded to the intervention treatment.

Contacts
Principal investigator
Name 102258 0
Dr Catherine Wall
Address 102258 0
University of Otago Christchurch
Department of Medicine
PO Box 4345, Christchurch 8140
Country 102258 0
New Zealand
Phone 102258 0
+64 272616130
Fax 102258 0
Email 102258 0
catherine.wall@otago.ac.nz
Contact person for public queries
Name 102259 0
Dr Catherine Wall
Address 102259 0
University of Otago Christchurch
Department of Medicine
PO Box 4345, Christchurch 8140
Country 102259 0
New Zealand
Phone 102259 0
+64 272616130
Fax 102259 0
Email 102259 0
catherine.wall@otago.ac.nz
Contact person for scientific queries
Name 102260 0
Dr Catherine Wall
Address 102260 0
University of Otago Christchurch
Department of Medicine
PO Box 4345, Christchurch 8140
Country 102260 0
New Zealand
Phone 102260 0
+64 272616130
Fax 102260 0
Email 102260 0
catherine.wall@otago.ac.nz

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?

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.