ANZCTR - Registration

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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

Type of registration

Retrospectively registered

Titles & IDs

Public title

The effect of early feeding into the gut on gut function after major colorectal surgery

Scientific title

The effect of early feeding into the gut on gut function after major colorectal surgery

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cancer

Condition category

Condition code

Cancer

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]

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]

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

Timepoint [1]

Assessed by records audit at discharge

Secondary outcome [1]

Time to first bowel movement - collected from medical notes

Timepoint [1]

Data will be collected post discharge

Secondary outcome [2]

prolonged postoperative ileus defined as more than 5 days without gastrointestinal function after surgery - collected from patient medical notes

Timepoint [2]

Data collected post discharge

Secondary outcome [3]

postoperative complications - collected from patient medical notes

Timepoint [3]

Data collected post discharge

Secondary outcome [4]

length of stay - collected from patient medical notes

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

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)

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.

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 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.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

7/11/2018

Date of last participant enrolment

Anticipated

29/05/2020

Actual

1/06/2020

Date of last data collection

Anticipated

30/05/2020

Actual

30/11/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment postcode(s) [1]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Prince Alfred Hospital

Address [1]

Building 12 Missendon Road
Camperdown NSW 2050

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Prince Alfred Hospital

Address

Building 12 Missendon Road
Camperdown NSW 2050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/08/2018

Approval date [1]

03/10/2018

Ethics approval number [1]

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

Ms Sophie Hogan

Address

Nutrition and Dietetics RPA
Building 12 Missendon Road
Camperdown NSW 2050

Country

Australia

Phone

+61 2 95158053

Fax

sophie.hogan@health.nsw.gov.au

Contact person for public queries

Name

Sophie Hogan

Address

Nutrition and Dietetics RPA
Building 12 Missendon Road
Camperdown NSW 2050

Country

Australia

Phone

+61 2 95158053

Fax

sophie.hogan@health.nsw.gov.au

Contact person for scientific queries

Name

Sophie Hogan

Address

Nutrition and Dietetics RPA
Building 12 Missendon Road
Camperdown NSW 2050

Country

Australia

Phone

+61 2 95158053

Fax

sophie.hogan@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Early enteral feeding is beneficial for patients after pelvic exenteration surgery: A randomized controlled trial.	2022	https://dx.doi.org/10.1002/jpen.2120

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically