Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000996167
Ethics application status
Approved
Date submitted
27/06/2019
Date registered
12/07/2019
Date last updated
12/07/2019
Date data sharing statement initially provided
12/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Early Nutrition Support in Neurosurgical Patients as guided by I-FEED scores
Scientific title
Early Nutrition Support in Neurosurgical Patients
-Prospective Cohort Study Utilising Post-operative Gastrointestinal Recovery Scores
Secondary ID [1] 298619 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition 313478 0
Postoperative nutrition 313479 0
Spinal surgery 313480 0
Condition category
Condition code
Surgery 311906 311906 0 0
Other surgery
Diet and Nutrition 311979 311979 0 0
Other diet and nutrition disorders
Anaesthesiology 311980 311980 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The authors have collaborated with the primary institution in order to incorporate the I-FEED score into the standardized care pathway of spinal neurosurgical patients. The I-FEED score is a decision making tool designed by the American Society for Enhanced Recovery and Perioperative Quality Initiative to facilitate assessment and guidance of postoperative feeding. This quality improvement initiative has been considered and will be implemented at an agreed timeframe between the authors and primary institution. This change will occur in January 2020. All appropriate stake holders have been educated in the implementation and clinical decision making as pertaining to the I-FEED scoring system. Following an agreed protocol change in post-operative nutrition management, the second cohort of patients will be observed. The second cohort will receive the newly implemented standard of care using the I-FEED score as a measure of post-operative gastro-intestinal function. I-FEED score will therefore guide the post-operative fasting period and time to oral nutrition. All usual peri-operative high standard care will be delivered as per surgeons and anaesthetists preferences in both cohorts of patients.I-FEED score is an international score designed to assess the postoperative gastrointestinal function.It is a decision making tool designed to guide the initiation of postoperative nutrition. Patients will receive a maximum 2 points for the categories of nausea, pain, intake, examination and duration of symptoms.
Intervention code [1] 314878 0
Diagnosis / Prognosis
Comparator / control treatment
The usual postoperative process where feeding is initiated by the nursing according to the classical subjective signs.
Control group
Active

Outcomes
Primary outcome [1] 320573 0
Primary clinically measured outcome
1.1 Time elapsed from wake up to solid oral intake. Time will be measured by recording the time difference in hours between the time at which patient has woken up to the time they have a first meal intake.
Timepoint [1] 320573 0
timepoint: time of first oral diet intake
Secondary outcome [1] 372087 0
Secondary clinically measured outcomes
1.2 Time elapsed to first clear fluid intake.Time will be measured by recording the time difference in hours at which patient has woken up to the time they have a first clear fluid intake.
Timepoint [1] 372087 0
Time at which the patient has first clear fluid intake
Secondary outcome [2] 372088 0

1.3.1 Rates of Post-operative Infection. This will be assessed through data linkage with medical records.
Timepoint [2] 372088 0
timepoint: Measured two days post-operatively.
Secondary outcome [3] 372089 0

1.4.1 Rates of post-operative infection, This will be assessed through data linkage with medical records.
Timepoint [3] 372089 0
timepjoint: Measured seven days post-operatively or at discharge, which ever happens first..
Secondary outcome [4] 372090 0
1.5 Time from admission to discharge home. Time will be measured in standard time units (hours) from admission to discharge home.
Timepoint [4] 372090 0
point in time at which patients have been discharged home.
Secondary outcome [5] 372091 0
1.6 Hospital Re-admission rates within a month of the surgical intervention.This outcome will be assessed through data linkage with medical records.
Timepoint [5] 372091 0
timepoint: 1 month after surgery
Secondary outcome [6] 372092 0
1.7 Patient Reported Outcome Measures (PROM) as
reflected in the QoR15 score (Quality of Recovery Score)
Timepoint [6] 372092 0
measured at 24 and 48 hours post surgery..
Secondary outcome [7] 372239 0
1.4.2 Gastrointestinal complications. Assessed through medical records with data linkage.
Known possible complications as diagnosed and recorded by medical team: ileus, nausea, vomiting, diarrhea, abdominal pain and vomiting.
Timepoint [7] 372239 0
Measured seven days post-operatively or at discharge, which ever happens first..

Eligibility
Key inclusion criteria
All adult patients having spinal neurosurgical procedures
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All patients where the Primary Care Provider (the Neurosurgeon in charge of the patient care) does not consider the agreed change of protocol implementation appropriate.
All patients who have a known intolerance to CHO supplements.
Patients who have self-reported poorly controlled unstable Diabetes
All patients who are unable to sign their own consent form.

All patients who need interpreting services.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Continuous summary outcome as measured by Mean and standard deviation
The outcome is Post-Operative number of hours until normal oral diet resumed as calculated by the number of hours difference between the time at which the patient has woken up to the time they have first solid meal intake.

Mean number of hours until oral intake for Control Group ……………………….8
Mean number of hours until oral intake for Study Group ……………………….6
Standard Deviation…………...........................................................................................................4

The statistical test T-test comparing two independent means of continuous outcomes

Alpha error Two-tailed P value < 0.05

Power 0.8

The calculated sample size per group assuming no loss of data is 64. We plan to enroll 70 patients per group to account for any potential loss of data to a total of 140.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2019
Actual
Date of last participant enrolment
Anticipated
1/08/2020
Actual
Date of last data collection
Anticipated
1/09/2020
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14120 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 26921 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 303160 0
Hospital
Name [1] 303160 0
St Vincent's Private Hospital
Country [1] 303160 0
Australia
Funding source category [2] 303256 0
Self funded/Unfunded
Name [2] 303256 0
Ana Licina
Country [2] 303256 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Private Hospital
Address
59 Victoria Parade
Fitzroy 3065
Victoria
Country
Australia
Secondary sponsor category [1] 303264 0
None
Name [1] 303264 0
Address [1] 303264 0
Country [1] 303264 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303722 0
St Vincents Hospital Melbourne Human Ethics Research Committee
Ethics committee address [1] 303722 0
Ethics committee country [1] 303722 0
Australia
Date submitted for ethics approval [1] 303722 0
Approval date [1] 303722 0
14/05/2019
Ethics approval number [1] 303722 0

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

Contacts
Principal investigator
Name 94570 0
Dr Andrew Silvers
Address 94570 0
St Vincent's Private Hospital
59 Victoria Parade
Fitzroy 3065
Victoria
Country 94570 0
Australia
Phone 94570 0
+61 3 9411 7111
Fax 94570 0
Email 94570 0
[email protected]
Contact person for public queries
Name 94571 0
Ana Licina
Address 94571 0
St Vincent's Private Hospital
59 Victoria Parade
Fitzroy 3065
Victoria
Country 94571 0
Australia
Phone 94571 0
+61 458490244
Fax 94571 0
Email 94571 0
[email protected]
Contact person for scientific queries
Name 94572 0
Ana Licina
Address 94572 0
St Vincent's Private Hospital
59 Victoria Parade
Fitzroy 3065
Victoria
Country 94572 0
Australia
Phone 94572 0
+61 458490244
Fax 94572 0
Email 94572 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2616Study protocol    377878-(Uploaded-27-06-2019-21-14-38)-Study-related document.docx
2617Informed consent form    377878-(Uploaded-27-06-2019-21-15-06)-Study-related document.doc
2618Ethical approval    377878-(Uploaded-27-06-2019-21-15-29)-Study-related document.pdf



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.