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Enhanced Recovery After Surgery (ERAS): Pilot Study of Carbohydrate (CHO) Loading Prior to Head and Neck Cancer Surgery

Enhanced Recovery After Surgery (ERAS): Feasibility of Pre-operative Carbohydrate (CHO)Loading in Patients Undergoing Major Head and Neck Cancer Surgery with Free Flap Reconstruction

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000218291
Acronym
ERAS in HNC
Enrollment
50
Registered
2018-02-09
Start date
2021-07-01
Completion date
Unknown
Last updated
2021-06-28

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 ERAS Study is examining the potential of pre-operative carbohydrates to improve post-operative recovery. Who is it for? You may be eligible for this study if you are aged above 18 years and are undergoing major surgery with free flap reconstruction for head and neck cancer. Study details The first of two groups in this study will receive standard care and be followed up for a number of outcomes after their procedure, including weight, BMI, blood biochemistry, length of hospital stay and surgical outcomes. The next group will receive a program of carbohydrate loading the night before their procedure, and have the same outcomes assessed after their procedure. It is hoped this study will contribute to the development of a preoperative carbohydrate program for patients undergoing surgery for head and neck cancer.

Interventions

In patients undergoing major surgery for head and neck cancer involving free flap reconstruction: Eligible patients will be approached for the trial and patient information sheet provided. The patient will be contacted following an indication of willingness to participate. Consent for the study will be signed during or before the pre-admission clinic visit and trial nutrition support product Nutricia PreOp will be provided for patients to self-administer loading dose (4 x 200mL) the night prior

In patients undergoing major surgery for head and neck cancer involving free flap reconstruction: Eligible patients will be approached for the trial and patient information sheet provided. The patient will be contacted following an indication of willingness to participate. Consent for the study will be signed during or before the pre-admission clinic visit and trial nutrition support product Nutricia PreOp will be provided for patients to self-administer loading dose (4 x 200mL) the night prior to attending for surgery with the remaining (2 x 200mL) to be ingested up to 2 hours prior to anaesthesia. Nutricia PreOp is a low osmolality, fibre and protein-free oral solution which contains carbohydrate polymers maltodextrin to facilitate glucose uptake and gastric emptying. The carbohydrate-rich oral solution provides 0.5kcal/mL and 12.5g CHO; 0g protein; 0g fat per 100mL with the study protocol as follow. Loading Dose (night before surgery): 800mL (400kcal, 100g CHO) Final Dose (2 hours prior to surgery): 400mL (200kal, 50g CHO) TOTAL: 1200mL (600kcal, 150g CHO) Adherence will be monitored by an intake diary. Standard care is per surgeon's instructions, typically fasting/nil by mouth for 4-6 hours prior to surgery.

Sponsors

Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

- Adult patients >18 years undergoing major surgery with free flap reconstruction for head and neck cancer - Able to speak adequate English to understand patient information sheet and give informed consent - Willingness to participate in the proposed research

Exclusion criteria

- Patients at high risk of refeeding syndrome as determined by pre-admission clinic dietitian assessment visit - Patients with dysphagia requiring thickened fluids - Patients with diabetes requiring insulin

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026