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Early Oral Feeding After Oral Malignancy Surgery

Effect of Early Oral Feeding in Intra-Oral Free Flap Reconstruction on Length of Hospital Stay: A Randomised Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001336471
Enrollment
124
Registered
2025-12-01
Start date
2025-12-31
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

None listed

Brief summary

This study aims to investigate the effect of early oral feeding (initiated within 5 days post-surgery) in comparison to traditional postoperative care involves withholding oral feeding for 7–12 days, in free flap reconstruction after head and neck cancer resection. Who is it for? Participants will be adults, who have undergone an intra-oral cancer resection who require a free tissue transfer for reconstruction and have not undergone previous radiation. Study details Patients will be randomised to either standard feedings (diet introduced at day 7 postoperatively) or early feeding (diet introduced day 1 postoperatively). Pre-operative and post operative swallowing assessments will be done by speech pathology. Data will also be collected on key outcomes such as nasogastric tube removal, days spent in hospital, and complications. It is hoped that findings from this study will help researchers and clinicians determine if early oral feeding offers benefits in terms of reduced hospital stay and faster recovery.

Interventions

The early introduction of diet, defined as before day 5 post operatively, in patients that have undergone intra-oral free flap reconstruction following resection of an intra-oral malignancy. The study will randomise patients to an early oral feeding group, or a control group to assess its impact on length of stay, swallowing outcomes and complications. The early oral feeding group will received sips of clear fluids day 1 (e.g. water, broth, plain gelatine), clear fluid diet day 3, and a free flu

The early introduction of diet, defined as before day 5 post operatively, in patients that have undergone intra-oral free flap reconstruction following resection of an intra-oral malignancy. The study will randomise patients to an early oral feeding group, or a control group to assess its impact on length of stay, swallowing outcomes and complications. The early oral feeding group will received sips of clear fluids day 1 (e.g. water, broth, plain gelatine), clear fluid diet day 3, and a free fluid diet day 4 (e.g. milk, ice cream, soups). Patients will receive nutritional supplementation via nasogastric tube, monitored by a dietician, which will be removed once meeting adequate oral intake, defined at meeting 50% of their calculated caloric intake through oral intake.

Sponsors

Metro South Health
Lead SponsorGovernment body

Study design

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

Eligibility

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

Inclusion criteria

Aged 18 years and over Oncological resection of the oral cavity (Lip, Floor of mouth, Tongue, retro-molar trigone, Buccal, Hard palate, Alveolus) Reconstruction of defect utilizing free tissue transfer

Exclusion criteria

Prior Radiation to the head and neck region An emergency return to theatre within the first 12 hours post-operatively

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026