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Trial registered on ANZCTR


Registration number
ACTRN12618001860257
Ethics application status
Approved
Date submitted
16/10/2018
Date registered
15/11/2018
Date last updated
15/11/2018
Date data sharing statement initially provided
15/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of early feeding into the gut on gut function after major colorectal surgery – a feasibility study
Scientific title
The effect of early enteral feeding on gut function in pelvic exenteration surgery – a feasibility study
Secondary ID [1] 296344 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 310058 0
Condition category
Condition code
Cancer 308816 308816 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants enrolled in the intervention arm will receive trophic (very low rate) enteral nutrition via a nasogastric tube. The nasogastric tube will be inserted during time of surgery (standard practice). Feeds will commence within 24 hours of surgery using a standard polymeric enteral feed which is already used frequently throughout the hospital. Enteral feeds will run for 20mL/hr (equivalent to one tablespoon every hour) over 24 hours until the participant’s diet is upgraded to full fluids, which will take approximately 3-5 days. Participants will commence TPN (standard practice at this site) the same time enteral nutrition starts. In most patients, the TPN infusion can be commenced at 60mL/h, or at the charted goal infusion rate if the patient has been receiving 5% dextrose at that goal rate for 4 hours and blood glucose levels have been stable. 40mL/h will be used if the patient is
suspected to be at risk of Refeeding Syndrome or glucose intolerance, or if the
patient’s body weight is low. If this happens, biochemistry will be monitored every 4 hours and TPN will be increased as determined by the clinician, using their clinical judgement, at this time point until it reaches goal rate. A combination of TPN and enteral nutrition will meet the participant’s nutritional requirements as determined by the dietitian. TPN will be increased as per standard practice. It should be noted there is currently no evidence for best feeding practice after pelvic exenteration surgery which is why this study is being implemented. If patients do not tolerate enteral feeds indicated by large aspirates identified by nursing staff, enteral feeding will cease.
Intervention code [1] 312669 0
Treatment: Other
Comparator / control treatment
Participants enrolled in the control arm will receive standard nutrition care. The definition of standard care is the use of TPN in ICU after their pelvic exenteration. Participant’s nutrition requirements will be calculated and the appropriate rate of TPN will be provided to meet their needs. As previously noted there has been no nutrition studies conducted in this cohort. Standard care is defined as per the site. This highlights the need for this study. The nutrition and medical team will provide the standard care.
Control group
Active

Outcomes
Primary outcome [1] 307791 0
Feasibility - Tolerance of trophic enteral feeds after pelvic exenteration surgery. Tolerance will be defined as the total amount of enteral feeds delivered via the nasogastric tube as a percentage of the total possible amount of enteral feeds delivered via the nasogastric tube until a full fluids diet is commenced
Timepoint [1] 307791 0
Once full fluids diet commenced
Secondary outcome [1] 352917 0
Time to first bowel movement - collected from medical notes
Timepoint [1] 352917 0
Data will be collected post discharge
Secondary outcome [2] 352918 0
prolonged postoperative ileus defined as more than 5 days without gastrointestinal function after surgery - collected from patient medical notes
Timepoint [2] 352918 0
Data collected post discharge
Secondary outcome [3] 353642 0
postoperative complications - collected from patient medical notes
Timepoint [3] 353642 0
Data collected post discharge
Secondary outcome [4] 353643 0
length of stay - collected from patient medical notes
Timepoint [4] 353643 0
At time of discharge

Eligibility
Key inclusion criteria
Pelvic exenteration for cancer and curative measures
18 years and over and able to provide written consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to consent due to language barriers or cognitive function
More than 3 enterotomies post surgery and the surgeon is concerned about the integrity of the gut

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
10 cards labeled intervention and 10 cards labeled control will be placed in opaque envelopes and randomly positioned in a box by an Associate Investigator. The Chief Investigator will open an envelope within 24 hours after surgery of a recruited participant and assign the participant to the relevant group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All data will be stored in REDCap database and statistical analyses will be performed using SPSS. Characteristics of patients randomised to each group will be compared. The percentage of enteral nutrition tolerated in the intervention group will be calculated. Secondary outcomes will be compared between the intervention and the control groups using unpaired two tailed t-test assuming unequal variance to inform future sample size calculations.

Recruitment
Recruitment status
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)
NSW
Recruitment hospital [1] 12187 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 24356 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 300946 0
Hospital
Name [1] 300946 0
Royal Prince Alfred Hospital
Address [1] 300946 0
Building 12 Missendon Road
Camperdown NSW 2050
Country [1] 300946 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Building 12 Missendon Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 300518 0
None
Name [1] 300518 0
Address [1] 300518 0
Country [1] 300518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301712 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 301712 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 301712 0
Australia
Date submitted for ethics approval [1] 301712 0
15/08/2018
Approval date [1] 301712 0
03/10/2018
Ethics approval number [1] 301712 0

Summary
Brief summary
The purpose of this study is to determine whether early feeding can help decrease gut side effects in patients who have received surgery for the removal of all pelvic organs (called pelvic exenteration and includes removal of the bladder, urethra, rectum and anus) as a radical surgery for the treatment of cancer.

Who is it for?

You may be eligible for this study if you are an adult who is going to have a pelvic exenteration surgery for cancer and other curative reasons.

Study details

Participants in this study will undergo their surgery as normal, and then during the surgery, will be randomly selected to be one of two groups.
Group 1: Will receive standard nutritional care after the operation.
Group 2: Will receive a feeding tube during the surgery, which will commence providing food within 24 hours from the end of the surgery up until the participant commences a full fluid diet. Tolerance and delivery of nutrition will be monitored.

It is hoped that this research will help determine if it is possible to commence feeding patients after their pelvic exenteration surgery and therefore reduce gut-related side effects.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87854 0
Ms Sophie Hogan
Address 87854 0
Nutrition and Dietetics RPA
Building 12 Missendon Road
Camperdown NSW 2050
Country 87854 0
Australia
Phone 87854 0
+61 2 95158053
Fax 87854 0
Email 87854 0
sophie.hogan@health.nsw.gov.au
Contact person for public queries
Name 87855 0
Ms Sophie Hogan
Address 87855 0
Nutrition and Dietetics RPA
Building 12 Missendon Road
Camperdown NSW 2050
Country 87855 0
Australia
Phone 87855 0
+61 2 95158053
Fax 87855 0
Email 87855 0
sophie.hogan@health.nsw.gov.au
Contact person for scientific queries
Name 87856 0
Ms Sophie Hogan
Address 87856 0
Nutrition and Dietetics RPA
Building 12 Missendon Road
Camperdown NSW 2050
Country 87856 0
Australia
Phone 87856 0
+61 2 95158053
Fax 87856 0
Email 87856 0
sophie.hogan@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All patients will be de-identified and individual patient data will not be made available
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable