Skip to content

Early enteral nutrition after Paediatric Ostomy Closure (EPOC): A Prospective Randomised Controlled Trial

Effect of Early enteral nutrition on the duration of hospital stay after Paediatric Ostomy Closure (EPOC): A Prospective Randomised Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001414808
Acronym
EPOC (Early enteral nutrition after Paediatric Ostomy Closure)
Enrollment
44
Registered
2021-10-20
Start date
2022-02-23
Completion date
2027-11-30
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

Following the closure of an enterostomy, post-operative fasting for a few days has been the norm, however, this prolonged fasting may not be necessary. Thus, we are planning a randomised control trial that compares the efficacy of early feeding with feeding after post-operative fasting in paediatric patients undertaking elective enterostomy closure. The hypothesis is that early feeding leads to shorter length of hospital stay, reduced pain, reduced rate of surgical complications and improved parent/carer satisfaction at discharge from hospital.

Interventions

Intervention Group – Early enteral nutrition (EEN) Oral feeds will be offered within 24 hours of admission to the recovery room. - Nasogastric Tube (NGT) is removed in theatre or in recovery - First feed is clear fluids, as tolerated - Subsequent feeds full fluids ad lib, as tolerated, entirely parent/carer/patient led. - Commence solids within 48 hours of admission to the recovery room ad lib, as tolerated, entirely parent/carer/patient led. - Vomiting – fast 4 hours then recommence clear fluid

Intervention Group – Early enteral nutrition (EEN) Oral feeds will be offered within 24 hours of admission to the recovery room. - Nasogastric Tube (NGT) is removed in theatre or in recovery - First feed is clear fluids, as tolerated - Subsequent feeds full fluids ad lib, as tolerated, entirely parent/carer/patient led. - Commence solids within 48 hours of admission to the recovery room ad lib, as tolerated, entirely parent/carer/patient led. - Vomiting – fast 4 hours then recommence clear fluids as above unless clinically contraindicated. - Adherence will be monitored using a bedside data sheet that will be filled out by the nursing staff.

Sponsors

Sydney Children's Hospital Network
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
3 Months to 16 Years
Healthy volunteers
No

Inclusion criteria

Paediatric patients between the ages of 3 months and 16 years who can be expected to feed orally after undergoing elective enterostomy closure for the following indications and operation type; - Elective closure of colostomy after Anorectal malformation (ARM) repair - Elective closure of colostomy/ileostomy after pull-through for Hirschsprung's disease (HSCR) - Elective closure of ileostomy after previous neonatal laparotomy for Necrotising enterocolitis (NEC), perforation, atresia or other intestinal pathology - Elective closure of colostomy/ileostomy where the stoma was formed at a previous laparotomy for other intra-abdominal pathology.

Exclusion criteria

• Patients with short gut requiring long term total parenteral nutrition (TPN) • Patients undergoing a total colectomy or gastrostomy closure • Intercurrent conditions expected to affect bowel function (e.g., neurological impairment) • Patients who have been assessed to have unsafe swallow or laryngeal penetration with reflux and vomiting. This includes inability to protect the airway due to neurological impairment or structural abnormality, due to aspiration risk • Inability to obtain consent from parent/guardian • Patients requiring specific individualised feeding regime (e.g., metabolic disease) • Patients who require prolonged nasogastric tube (NGT) feeding • Patients requiring more than a simple enterostomy closure; i.e., extensive adhesiolysis or more than one anastomosis (in NEC) • Patients with Cystic Fibrosis or Inflammatory Bowel Disease.

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 28, 2026