Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000955213
Ethics application status
Not yet submitted
Date submitted
4/11/2009
Date registered
5/11/2009
Date last updated
10/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the Clear Fluids Diet: A comparison between patients commencing on Clear Fluids or Free Fluids and the effect this has on post-operative outcomes after elective large bowel surgery.
Scientific title
The efficacy of the Clear Fluids Diet: The effect on post-operative outcomes when patients are commenced on either Clear Fluid or Free Fluid Diets post elective colorectal surgery.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elective colorectal surgery for inflammatory bowel disease, diverticular disease or cancer. 252121 0
Condition category
Condition code
Surgery 252325 252325 0 0
Other surgery
Oral and Gastrointestinal 252335 252335 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
Patients commence on sips of water ad libitum day 1 post-operatively. Once the treating surgeon deems the patient appropriate to commence fluids, they will start on Free Fluids ad libitum, (usually for 1-4 days), then Light Diet ad libitum (1-2 days) and then to Full Diet ad libitum (until discharged)
Free Fluids are defined as low fibre foods which are fluid like in nature at room temperature including, all Clear Fluids, milk and soy based drinks and nutrition supplements, strained porridge, pureed soup, ice-cream, plain yoghurt and custard
Intervention code [1] 241501 0
Treatment: Other
Comparator / control treatment
Patients commence on sips of water ad libitum day 1 post-operatively. Once the treating surgeon deems the patient appropriate to commence fluids they then progress to clear fluids ad libitum, usually for 1-4 days. If patients continue to tolerate they progress to Free Fluids ad libitum, (usually for 1-4 days), then Light Diet ad libitum (1-2 days) and then to Full Diet ad libitum (until discharged)

Clear Fluids as transparent, low residue and fat-free fluids. This includes water, tea, coffee, cordial, broth, strained juice and juice-based nutritional supplements
Control group
Active

Outcomes
Primary outcome [1] 253199 0
Number of days of hospital admission post surgery collected from medical records.
Timepoint [1] 253199 0
At discharge from Frankston Hospital
Primary outcome [2] 253200 0
Post-operative complications including ileus, anastomotic breakdown and wound breakdown as documented in the medical history by the medical team.

Pneumonia (from chest xray showing positive infiltrates and positive sputum culture), urinary tract infection (positive urine cultures), sepsis (temperature greater than 38 degrees, heart rate above 90 bpm, respiratory rate greater that 20 rpm and white cell count above 12 x10^9/L or less than 4 x10^9/L or more than 10 % band forms in the absence of chemotherapy induced neutropenia or leukopenia) and mortality from medical history.
Timepoint [2] 253200 0
Incidence of complications will be collected during hospital admission
Primary outcome [3] 253201 0
Proportion of nutritional requirements met using food and fluid chart analysis. Nutritional requirements will be calculated using the Schofield Equation.
Timepoint [3] 253201 0
Until patient is tolerating Light Diet for 24 hours
Secondary outcome [1] 262131 0
Patient satisfaction with the Clear and Free Fluid Diets using a modified Department of Human Services Metropolitan Health Services Meal Service questionnaire
Timepoint [1] 262131 0
The day after the patients is commenced on Clear or Free Fluids

Eligibility
Key inclusion criteria
Patients undergoing elective colorectal surgery who would require clear fluids post operatively
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients receiving enteral or parenteral nutrition support

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243975 0
Hospital
Name [1] 243975 0
Peninsula Health
Country [1] 243975 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health
Address
Frankston Hospital
Hastings Road
Frankston
VIC 3181
Country
Australia
Secondary sponsor category [1] 251326 0
None
Name [1] 251326 0
Address [1] 251326 0
Country [1] 251326 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 244084 0
Ethics committee address [1] 244084 0
Ethics committee country [1] 244084 0
Date submitted for ethics approval [1] 244084 0
06/11/2009
Approval date [1] 244084 0
Ethics approval number [1] 244084 0

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

Contacts
Principal investigator
Name 30461 0
Address 30461 0
Country 30461 0
Phone 30461 0
Fax 30461 0
Email 30461 0
Contact person for public queries
Name 13708 0
Neha Kaul
Address 13708 0
Level One
Frankston Hospital
Hastings Road
Frankston
VIC 3181
Country 13708 0
Australia
Phone 13708 0
61 3 9784 8243
Fax 13708 0
Email 13708 0
[email protected]
Contact person for scientific queries
Name 4636 0
Neha Kaul
Address 4636 0
Level One
Frankston Hospital
Hastings Road
Frankston
VIC 3181
Country 4636 0
Australia
Phone 4636 0
61 3 9784 8243
Fax 4636 0
Email 4636 0
[email protected]

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.