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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
23/09/2021
Date data sharing statement initially provided
15/11/2018
Date results information initially provided
23/09/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effect of early feeding into the gut on gut function after major colorectal surgery
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Scientific title
The effect of early feeding into the gut on gut function after major colorectal surgery
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Secondary ID [1]
296344
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
cancer
310058
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Condition category
Condition code
Cancer
308816
308816
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0
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Any cancer
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
312669
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
307791
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Time to first bowel movement (defecation)
This will be assessed by direct observation by personnel looking after the patient who will record this in medical notes. Medical records will then be audited
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Assessment method [1]
307791
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Timepoint [1]
307791
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Assessed by records audit at discharge
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Secondary outcome [1]
352917
0
Time to first bowel movement - collected from medical notes
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Assessment method [1]
352917
0
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Timepoint [1]
352917
0
Data will be collected post discharge
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Secondary outcome [2]
352918
0
prolonged postoperative ileus defined as more than 5 days without gastrointestinal function after surgery - collected from patient medical notes
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Assessment method [2]
352918
0
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Timepoint [2]
352918
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Data collected post discharge
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Secondary outcome [3]
353642
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postoperative complications - collected from patient medical notes
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Assessment method [3]
353642
0
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Timepoint [3]
353642
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Data collected post discharge
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Secondary outcome [4]
353643
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length of stay - collected from patient medical notes
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Assessment method [4]
353643
0
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Timepoint [4]
353643
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At time of discharge
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Eligibility
Key inclusion criteria
Pelvic exenteration for cancer and curative measures
18 years and over and able to provide written consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
25 cards labeled intervention and 25 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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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 time to first bowel motion will be compared between groups using unpaired two tailed t-tests. Secondary outcomes will be compared between the intervention and the control groups using unpaired two tailed t-tests, anovas and regressions to determine sig. differences between the groups.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
7/11/2018
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Date of last participant enrolment
Anticipated
29/05/2020
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Actual
1/06/2020
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Date of last data collection
Anticipated
30/05/2020
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Actual
30/11/2020
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Sample size
Target
70
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Accrual to date
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Final
87
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
12187
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Royal Prince Alfred Hospital - Camperdown
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Recruitment postcode(s) [1]
24356
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2050 - Camperdown
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Funding & Sponsors
Funding source category [1]
300946
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Hospital
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Name [1]
300946
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Royal Prince Alfred Hospital
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Address [1]
300946
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Building 12 Missendon Road
Camperdown NSW 2050
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Country [1]
300946
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Australia
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Primary sponsor type
Hospital
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Name
Royal Prince Alfred Hospital
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Address
Building 12 Missendon Road
Camperdown NSW 2050
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Country
Australia
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Secondary sponsor category [1]
300518
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None
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Name [1]
300518
0
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Address [1]
300518
0
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Country [1]
300518
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301712
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Sydney Local Health District Ethics Review Committee (RPAH Zone)
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Ethics committee address [1]
301712
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Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
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Ethics committee country [1]
301712
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Australia
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Date submitted for ethics approval [1]
301712
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15/08/2018
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Approval date [1]
301712
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03/10/2018
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Ethics approval number [1]
301712
0
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
87854
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Ms Sophie Hogan
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Address
87854
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Nutrition and Dietetics RPA
Building 12 Missendon Road
Camperdown NSW 2050
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Country
87854
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Australia
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Phone
87854
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+61 2 95158053
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Fax
87854
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Email
87854
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sophie.hogan@health.nsw.gov.au
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Contact person for public queries
Name
87855
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Ms Sophie Hogan
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Address
87855
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Nutrition and Dietetics RPA
Building 12 Missendon Road
Camperdown NSW 2050
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Country
87855
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Australia
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Phone
87855
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+61 2 95158053
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Fax
87855
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Email
87855
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sophie.hogan@health.nsw.gov.au
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Contact person for scientific queries
Name
87856
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Ms Sophie Hogan
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Address
87856
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Nutrition and Dietetics RPA
Building 12 Missendon Road
Camperdown NSW 2050
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Country
87856
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Australia
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Phone
87856
0
+61 2 95158053
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Fax
87856
0
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Email
87856
0
sophie.hogan@health.nsw.gov.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
All patients will be de-identified and individual patient data will not be made available
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What supporting documents are/will be available?
No other documents available
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Summary results
Have study results been published in a peer-reviewed journal?
No
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Other publications
Have study results been made publicly available in another format?
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Results – basic reporting
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Results – plain English summary
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