Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000796189p
Ethics application status
Submitted, not yet approved
Date submitted
21/05/2019
Date registered
30/05/2019
Date last updated
7/07/2020
Date data sharing statement initially provided
30/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pre-operative Very Low Energy Diet in Laparoscopic Surgery: A Pilot Study
Scientific title
Effect of Very Low Energy Diet (VLED) on Pre-Operative Weight Loss in Laparoscopic Colorectal Surgery: A Pilot Study
Secondary ID [1] 298297 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Surgery 312925 0
Obesity 312926 0
Condition category
Condition code
Surgery 311418 311418 0 0
Other surgery
Diet and Nutrition 311500 311500 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The VLED used in this study will be the Optifast intensive program. This consists of 3 to 5 Optifast shakes (dependent on body weight) daily, in addition to two cups of low-starch vegetables, plus one teaspoon of vegetable oil. A protein target of 0.75g/kg of actual body weight will be achieved through the Optifast shakes, with the addition of Beneprotein supplementation if necessary. The Optifast and Beneprotein will be administered by the dietician and will be provided to the participant for the duration of the study.
The duration of VLED will be from commencement of the study to date of surgery, this will be a maximum of 4 weeks.
A combination of daily food diary and weekly telephone call from the dietician will be used to monitor adherence to the VLED.
Intervention code [1] 314531 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320137 0
Total weight loss in kilograms for the entire duration of the VLED program. This will be measured using electronic weight scales.
Timepoint [1] 320137 0
From commencement to day of surgery (up to 4 weeks)
Secondary outcome [1] 370670 0
Duration of treatment (days). This will be assessed using a participant food diary and weekly telephone calls from the dietician.
Timepoint [1] 370670 0
From commencement to day of surgery (up to 4 weeks)

Eligibility
Key inclusion criteria
BMI greater than 30
Undergoing elective laparoscopic colorectal procedure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give consent
Unintentional loss of weight greater than 5% of body weight in the last six months
Insulin-dependent diabetes mellitus
Congestive heart failure requiring diuretic therapy
Stage 3 chronic kidney disease
Child's Pugh B or C chronic liver disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
1/02/2022
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13807 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 26558 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 302840 0
Hospital
Name [1] 302840 0
The Northern Hospital
Country [1] 302840 0
Australia
Primary sponsor type
Individual
Name
Basil D'Souza
Address
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country
Australia
Secondary sponsor category [1] 302788 0
Hospital
Name [1] 302788 0
The Northern Hospital
Address [1] 302788 0
185 Cooper Street
Epping VIC 3076
Country [1] 302788 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303418 0
Austin Health HREC
Ethics committee address [1] 303418 0
145 Studley Road
PO Box 5555 Heidelberg VIC 3084
Ethics committee country [1] 303418 0
Australia
Date submitted for ethics approval [1] 303418 0
15/05/2019
Approval date [1] 303418 0
Ethics approval number [1] 303418 0

Summary
Brief summary
This study is a pilot study looking at the efficacy and feasibility of pre-operative very low energy diet in patients with BMI greater than 30, prior to laparoscopic colorectal study. Participants will be prescribed the Optifast Intensive Program on a daily basis after enrolment in the study and will take the Optifast meal replacement until the day of surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93610 0
Mr Basil D'Souza
Address 93610 0
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 93610 0
Australia
Phone 93610 0
+61 384058000
Fax 93610 0
Email 93610 0
[email protected]
Contact person for public queries
Name 93611 0
Mr Basil D'Souza
Address 93611 0
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 93611 0
Australia
Phone 93611 0
+61 384058000
Fax 93611 0
Email 93611 0
[email protected]
Contact person for scientific queries
Name 93612 0
Mr Basil D'Souza
Address 93612 0
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 93612 0
Australia
Phone 93612 0
+61 384058000
Fax 93612 0
Email 93612 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.