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

Not Applicable

Recruiting

• Conditions: Ostomy closure; Surgery - Other surgery; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12621001414808
• Lead Sponsor: Sydney Children's Hospital Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-20
• Last Update Posted: 21 June 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ength of stay. This will be obtained from the patient's electronic medical records.[Hours from admission to recovery room to hospital discharge.]