Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001414808
Ethics application status
Approved
Date submitted
6/09/2021
Date registered
20/10/2021
Date last updated
14/06/2023
Date data sharing statement initially provided
20/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Early enteral nutrition after Paediatric Ostomy Closure (EPOC): A Prospective Randomised Controlled Trial
Scientific title
Effect of Early enteral nutrition on the duration of hospital stay after Paediatric Ostomy Closure (EPOC): A Prospective Randomised Controlled Trial
Secondary ID [1] 304689 0
Nil known
Universal Trial Number (UTN)
U1111-1267-7456
Trial acronym
EPOC (Early enteral nutrition after Paediatric Ostomy Closure)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ostomy closure 322672 0
Condition category
Condition code
Surgery 320287 320287 0 0
Other surgery
Oral and Gastrointestinal 320288 320288 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 321065 0
Treatment: Other
Comparator / control treatment
Control
- NGT remains in place post operatively
- Commence feeds on return of bowel function or when aspirates are no longer green. Return of bowel function is defined as the passage of flatus or stool or once NGT aspirates have become non-bilious, typically after around 2-3 days of fasting.
- Start with clear fluids as tolerated
- Remove NGT as per surgeon
- Grade up through full fluids and solids as tolerated, as in the EEN group.
Control group
Active

Outcomes
Primary outcome [1] 328141 0
Length of stay. This will be obtained from the patient's electronic medical records.
Timepoint [1] 328141 0
Hours from admission to recovery room to hospital discharge.
Secondary outcome [1] 397802 0
Time to first oral feed
(a) clear fluids
(b) full fluids
(c) solids
(d) full enteral intake

This will be assessed as a composite outcome. This will be assessed using a bedside data sheet that staff will fill out.
Timepoint [1] 397802 0
Hours from admission to recovery room to full feeds.
Secondary outcome [2] 397803 0
Rate of post-operative complications - including; surgical site infection, anastomotic leak, ileus, bowel obstruction, unplanned return to theatre, sepsis, vomiting (number and time to first vomit). time to feeds ceased/restarted, constipation, diarrhoea, nappy rash with skin breakdown, enterocutaneous fistula, respiratory complications and readmission to hospital. This will be obtained from the patient's electronic medical records and the bedside data sheet.
Timepoint [2] 397803 0
Any of the above complications that occur within 30 days post-operation.
Secondary outcome [3] 397804 0
Analgesia use - duration of IV narcotic analgesia (hours). This will be obtained from the patient's electronic medical records.
Timepoint [3] 397804 0
From admission to recovery room to hospital discharge.
Secondary outcome [4] 397805 0
Highest post-operative pain score. This will be assessed using the r-FLACC tool for children between the ages of 3 months and 3 years. The Wong-Baker faces pain scale will be used for children between the ages of 3 years and 8 years. The Visual Analogue Scale (VAS) will be used for children over the age of 8 years.
Timepoint [4] 397805 0
From admission to recovery room to hospital discharge. These will be measured during routine observations every 4 hours.
Secondary outcome [5] 397806 0
Highest post-operative temperature (over 38C). This will be assessed using a digital thermometer and charted in the patient's electronic medical records.
Timepoint [5] 397806 0
From admission to recovery room to hospital discharge. This will be measured during routine observations every 4 hours.
Secondary outcome [6] 397807 0
Total oral narcotic doses. This will be obtained from the patient's electronic medical records.
Timepoint [6] 397807 0
From admission to recovery room to hospital discharge.
Secondary outcome [7] 397808 0
Total paracetamol doses. This will be obtained from the patient's electronic medical records.
Timepoint [7] 397808 0
From admission to recovery room to hospital discharge.
Secondary outcome [8] 397809 0
Total Nurofen doses. This will be obtained from the patient's electronic medical records.
Timepoint [8] 397809 0
From admission to recovery room to hospital discharge.
Secondary outcome [9] 397810 0
Time to pass first stool (hours). This will be obtained from the patient's electronic medical records and the bedside data sheet.
Timepoint [9] 397810 0
From admission to recovery room to first stool.
Secondary outcome [10] 397811 0
Parent satisfaction score at discharge. This will be assessed using a study-specific questionnaire.
Timepoint [10] 397811 0
At discharge.
Secondary outcome [11] 400123 0
Discharge height. For babies this is the lying down one and for children who can stand it will be through stadiometer.
Timepoint [11] 400123 0
At discharge.
Secondary outcome [12] 400124 0
Discharge weight. This will be assessed using a size and age appropriate digital scale.
Timepoint [12] 400124 0
At discharge.

Eligibility
Key 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.
Minimum age
3 Months
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment is achieved as randomisation will occur once the child arrives in the recovery room. Thus, when assessing whether patients are eligible for inclusion in the trial, investigators will not know which group the patient will be allocated to. Further, by randomising immediately after surgery, the surgeons will not know which group the patient will be allocated to. Upon admission to the recovery room, randomisation will occur by using sealed opaque envelopes that have been prepared in advance by a biostatistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified permitted block randomisation will be prepared by a biostastician. Patients will be stratified by type of stoma closure (small bowel stoma closure vs colostomy closure), hospital type and age (3 months - 5 years vs 6 years - <16 years), giving a total of 8 blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A sample size of 40 patients is required for this study. We are planning a RCT, with the outcome measure being continuous length of stay, comparing 2 independent groups: control and EEN patients with 1 control per EEN patient.

Analysis will be performed according to the intention-to-treat principle, whereby participants are analysed in their randomised treatment group, regardless of the treatment they received. Continuous variables will be characterised by mean and standard deviation for normally distributed data and median and interquartile range for non-normally distributed data. They will be compared using an independent sample T-test if normally distributed and Mann-Whitney U test where not normally distributed. Time to full feeds and passing of stool will be described using Kaplan Meier survival analysis and compared using the log-rank test.

Categorical variables will be characterised by frequencies and percentages and compared using Chi-square test, and Fishers exact test where cell size is less than 5.

Sample size justification
In a previous study mean LOS was 7.2 and 9.4 days within early feeding and standard care groups, respectively, with a standard deviation of 2.1. Historical data in our clinic showed mean (SD) LOS of 3.67 (0.99) and 5.91 (2.5) days in 17 patients offered full feeds within 48 hours of surgery and 18 patients offered full feeds more than 48 hours after surgery, respectively. This reduction in LOS is considered clinically important. A study of 34 participants randomised 1:1 will have 80% power at 5% two-sided alpha to detect a difference of one standard deviation in the mean of a normally distributed outcome. To account for some withdrawal and loss to follow up, we plan to recruit a total of 40 patients.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/01/2022
Actual
23/02/2022
Date of last participant enrolment
Anticipated
17/07/2024
Actual
Date of last data collection
Anticipated
20/08/2024
Actual
Sample size
Target
40
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19912 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 19913 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 34611 0
2031 - Randwick
Recruitment postcode(s) [2] 34612 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 309097 0
Hospital
Name [1] 309097 0
Sydney Children's Hospital Network
Country [1] 309097 0
Australia
Primary sponsor type
Hospital
Name
Sydney Children's Hospital Network
Address
Sydney Children's Hospital Randwick, High St, Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 310040 0
University
Name [1] 310040 0
University of New South Wales (UNSW)
Address [1] 310040 0
UNSW Sydney, NSW, 2052
Country [1] 310040 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308910 0
Sydney Children's Hospital Network Human Research Ethics Committee
Ethics committee address [1] 308910 0
Ethics committee country [1] 308910 0
Australia
Date submitted for ethics approval [1] 308910 0
28/06/2021
Approval date [1] 308910 0
18/08/2021
Ethics approval number [1] 308910 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112310 0
Dr Susan Adams
Address 112310 0
Department of Paediatric Surgery, Sydney Children’s Hospital, High St, Randwick, NSW, 2031.
Country 112310 0
Australia
Phone 112310 0
+61 2 9382 1776
Fax 112310 0
Email 112310 0
[email protected]
Contact person for public queries
Name 112311 0
Susan Adams
Address 112311 0
Department of Paediatric Surgery, Sydney Children’s Hospital, High St, Randwick, NSW, 2031.
Country 112311 0
Australia
Phone 112311 0
+61 2 9382 1776
Fax 112311 0
Email 112311 0
[email protected]
Contact person for scientific queries
Name 112312 0
Susan Adams
Address 112312 0
Department of Paediatric Surgery, Sydney Children’s Hospital, High St, Randwick, NSW, 2031.
Country 112312 0
Australia
Phone 112312 0
+61 2 9382 1776
Fax 112312 0
Email 112312 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.