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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001860257
Enrollment
87
Registered
2018-11-15
Start date
2018-11-07
Completion date
2020-06-01
Last updated
2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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,

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.

Sponsors

Royal Prince Alfred Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Pelvic exenteration for cancer and curative measures 18 years and over and able to provide written consent

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026