Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000868987
Ethics application status
Approved
Date submitted
15/08/2011
Date registered
16/08/2011
Date last updated
19/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting Recovery and Enhancing Outcomes Pre and Post Surgery (PREOPPS): Effects of preoperative oral carbohydrate loading on clinical outcomes.
Scientific title
In patients undergoing bowel resection, does administration of preoperative oral carbohydrate-rich nutritional supplement reduce length of hospital stay?
Secondary ID [1] 262829 0
Nil
Universal Trial Number (UTN)
Trial acronym
PREOPPS trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel surgery 270554 0
Condition category
Condition code
Diet and Nutrition 270715 270715 0 0
Other diet and nutrition disorders
Surgery 270719 270719 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomised to the intervention arm of the study will be asked to drink 800ml of the CHO (Nutrica PreOp [registered trademark] solution) between 1900 and 2400 hours on the night before surgery and to have no solid food from midnight. The beverage is a clear fluid with 50 kcal per 100 ml, 290 mOsm/kg, and a pH of 5.0). In accordance with the RBWH protocol, other clear fluids may be taken during the night. At 0500 hours on the morning of surgery, patients will be asked to drink a further 400mls of the solution and to record any side-effects caused by the drink. No further fluids are permitted before surgery.
Intervention code [1] 269183 0
Treatment: Other
Comparator / control treatment
Patients randomised to the control arm of the study will follow the RBWH protocol, that is, they must not take solid food from midnight but may drink clear fluids up to 0500 hours.
Control group
Active

Outcomes
Primary outcome [1] 269427 0
Time to readiness for discharge: Time in days (or hours) until the following criteria are met: passing flatus, stool and urine; eating satisfactorily; managing on oral analgesics; afebrile; mobilising independently to shower and toilet; requiring wound dressing changes less that twice daily; without drains requiring inpatient management.
Timepoint [1] 269427 0
At hospital discharge
Secondary outcome [1] 287614 0
Time to first flatus (patient self-report)
Timepoint [1] 287614 0
Up to one week post surgery
Secondary outcome [2] 287615 0
Time to first bowel movement (patient self-report)
Timepoint [2] 287615 0
Up to one week post surgery
Secondary outcome [3] 287616 0
Mortality: death from any cause whilst on the trial
Timepoint [3] 287616 0
Up to one month post surgery
Secondary outcome [4] 287617 0
Adverse outcomes (such as re-admission, aspiration, any reaction or side effects caused by the drink).
Timepoint [4] 287617 0
Up to one month post surgery

Eligibility
Key inclusion criteria
1) Informed written consent
2) Booked for elective bowel resection at the RBWH
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) < 18 years age
2) Non-English speaking patients without an interpreter
3) Pregnant
4) Inability to consume clear fluids
5) Gastrointestinal obstruction
6) Liver cirrhosis,
7) Diabetes mellitus
8) Corticosteroid treatment exceeding 5 mg/day.

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)
If a patient meets all inclusion and no exclusion criteria, the research nurse will obtain group allocation via a telephone service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use a computer generated randomised list to determine allocation sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomisation will be in a 1:1 ratio between the two study groups. Block randomisation will be used.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/08/2011
Actual
24/08/2011
Date of last participant enrolment
Anticipated
Actual
6/04/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269654 0
Charities/Societies/Foundations
Name [1] 269654 0
RBWH Research Foundation
Country [1] 269654 0
Australia
Primary sponsor type
Individual
Name
Joan Webster
Address
Level 2, Bld 34
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 266693 0
None
Name [1] 266693 0
Address [1] 266693 0
Country [1] 266693 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269601 0
Royal Brisbane and Women's Hospital Research Ethics Committee
Ethics committee address [1] 269601 0
Ethics committee country [1] 269601 0
Australia
Date submitted for ethics approval [1] 269601 0
24/01/2011
Approval date [1] 269601 0
01/06/2011
Ethics approval number [1] 269601 0
HREC/11QRBW/39

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

Contacts
Principal investigator
Name 33015 0
Ms Angela Swift
Address 33015 0
Maternity Services
RBWH
Butterfield Street
Herston QLD 4029
Country 33015 0
Australia
Phone 33015 0
+61 7 3646 8590
Fax 33015 0
Email 33015 0
angela_swift@health.qld.gov.au
Contact person for public queries
Name 16262 0
Joan Webster
Address 16262 0
Level 2, Bld 34
RBWH
Butterfield St
Herston, QLD 4169
Country 16262 0
Australia
Phone 16262 0
+61 7 3636 8590
Fax 16262 0
Email 16262 0
joan_webster@health.qld.gov.au
Contact person for scientific queries
Name 7190 0
Joan Webster
Address 7190 0
Level 2, Bld 34
RBWH
Butterfield St
Herston QLD 4169
Country 7190 0
Australia
Phone 7190 0
+61 7 3636 8590
Fax 7190 0
Email 7190 0
joan_webster@health.qld.gov.au

No information has been provided regarding IPD availability


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.