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Trial registered on ANZCTR


Registration number
ACTRN12609000219280
Ethics application status
Approved
Date submitted
2/03/2009
Date registered
30/04/2009
Date last updated
17/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Individualised nutritional counselling for patients who have undergone major upper gastrointestinal surgery - a randomised controlled trial
Scientific title
A randomised controlled trial assessing weight change in individualised nutritional counselling for patients who have undergone major upper gastrointestinal surgery
Secondary ID [1] 288179 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Upper Gastrointestinal surgery 4401 0
Condition category
Condition code
Oral and Gastrointestinal 4651 4651 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 4652 4652 0 0
Other surgery
Public Health 4975 4975 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will recieve a one-on-one 30 minute nutrition counselling session with a Dietitian on the ward prior to discharge to discuss eating after surgery. Basic information is covered such as small frequent meals and high energy/protein food choices. This is current practice. Then patients are randomised into a control group or intervention. The intevention group are contacted by the Dietitian by phone every 2 weeks for 6 months and face to face at 1 and 3 months. This nutrition couselling will include assessing intake, weight and symptoms, and giving relevant nutrition advice based on this.
Intervention code [1] 4134 0
Behaviour
Comparator / control treatment
Patients will recieve a one-on-one 30 minute nutrition counselling session with a Dietitian on the ward prior to discharge to discuss eating after surgery. Basic information is covered such as small frequent meals and high energy/protein food choices. This is current practice
Control group
Active

Outcomes
Primary outcome [1] 5520 0
Weight change - A Dietitian (seperate to the Dietitian giving nutrition counselling) will see the patient when they attend appointments with the consultant surgeon and weigh the patient.
Timepoint [1] 5520 0
Data will be collected at 1, 3 and 6 months post discharge from hospital.
Secondary outcome [1] 9290 0
Quality of life using the European Organisation for Research and treatment of Cancer Quality of Life Core Questionnaire (EORTC-QLQ-C30).
Timepoint [1] 9290 0
1, 3 and 6 months post discharge from hospital
Secondary outcome [2] 9291 0
Symptom Management (Gastrointestinal Symptom Rating Scale)
Timepoint [2] 9291 0
1, 3 and 6 months post discharge from hospital as per primary outcome.

Eligibility
Key inclusion criteria
All patients undergoing Ivor-lewis Oesphagectomy, Partial or Total Gastrectomy, or Whipples surgery for non-neoplasm or curative neoplasm reasons.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known metastatic disease
Rural patient not to be followed up by Royal Prince Alfred Hospital (RPAH) surgeons

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will already be under the care of a Dietitian while in hospital. Prior to discharge they will be invited to participate in the study. If they agree to be involved baseline data will be collected (weight, Quality Of Life, symptoms) and baseline nutrition education will be given. Patient names for those that enrol in the study will be passed on to a third party who will randomise using numbered containers. The third party will pass the details of those allocated to the intervention on to the Dietitian responsible for nutrition counselling, while the orginal Dietitian who is responsible for collecting data will see every patient in the consultant surgeons rooms at 1,3 and 6 months.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation according to type of surgery (oesphagectomy, gastrectomy and whipples), and then a simple randomisation based on a table from a text book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
1/04/2009
Date of last participant enrolment
Anticipated
Actual
30/11/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4581 0
Self funded/Unfunded
Name [1] 4581 0
Sharon Lamb
Country [1] 4581 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Nutrition and Dietetics Department
Level 6, King George V (KGV) Building
Missenden Road
Royal Prince Alfred Hospital (RPAH)
Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 4130 0
University
Name [1] 4130 0
University of Sydney
Address [1] 4130 0
University of Sydney
City Road
Camperdown, NSW 2006
Country [1] 4130 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6628 0
Royal Prince Alfred Hospital
Ethics committee address [1] 6628 0
Ethics committee country [1] 6628 0
Australia
Date submitted for ethics approval [1] 6628 0
10/02/2009
Approval date [1] 6628 0
01/03/2009
Ethics approval number [1] 6628 0
HREC/09/RPAH/36

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

Contacts
Principal investigator
Name 29335 0
Dr Sharon Carey
Address 29335 0
Nutrition and Dietetics
Royal Prince Alfred Hospital
Camperdown
NSW 2050
Australia
Country 29335 0
Australia
Phone 29335 0
+61295157863
Fax 29335 0
Email 29335 0
sharon.carey@sswahs.nsw.gov.au
Contact person for public queries
Name 12582 0
Sharon Lamb
Address 12582 0
Nutrition and Dietetics Department
Level 6, King George V (KGV) Building
Missenden Road
Royal Prince Alfred Hospital (RPAH)
Camperdown, NSW, 2050
Country 12582 0
Australia
Phone 12582 0
+612 95157863
Fax 12582 0
+612 9515 5047
Email 12582 0
sharon.lamb@sswahs.nsw.gov.au
Contact person for scientific queries
Name 3510 0
Sharon Lamb
Address 3510 0
Nutrition and Dietetics Department
Level 6, King George V (KGV) Building
Missenden Road
Royal Prince Alfred Hospital (RPAH)
Camperdown, NSW, 2050
Country 3510 0
Australia
Phone 3510 0
+612 95157863
Fax 3510 0
+612 95155047
Email 3510 0
sharon.lamb@sswahs.nsw.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.