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Trial registered on ANZCTR


Registration number
ACTRN12615000646549
Ethics application status
Not yet submitted
Date submitted
3/06/2015
Date registered
23/06/2015
Date last updated
23/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Jejunal versus oral nutrition support for one month after discharge from hospital following oesphagectomy or total gastrectomy - A randomised controlled trial.
Scientific title
In patients discharged from hospital following oesphagectomy or total gastrectomy, what is the effect of one month of jejunal versus oral nutrition support on body weight? A randomised controlled trial
Secondary ID [1] 286857 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophagectomy 295251 0
Total gastrectomy 295252 0
Condition category
Condition code
Diet and Nutrition 295497 295497 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 295557 295557 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
One month of overnight continuous jejunal tube feeding using Nutrison Multifibre Energy via an infinity pump for 10 hours from 8pm - 6am after discharge from hospital following oesophagectomy or total gastrectomy, providing 900 calories per night.
Patients will administer their own enteral nutrition.
Adherence will be monitored at time of follow up with stock checks.
Intervention code [1] 292024 0
Treatment: Other
Intervention code [2] 292069 0
Treatment: Devices
Comparator / control treatment
One month of oral nutrition support (made up from 3 Nutrison Fortisip drinks per day, spread throughout the day to fit in wiht individual meal plans) for one month on discharge from hospital following oesophagectomy or total gastrectomy, providing 900 calories per day.
Adherence will be monitored at time of follow up with stock checks.
Control group
Active

Outcomes
Primary outcome [1] 295231 0
Weight (reported in kilograms) - using calibrated scales (and patient recall over the phone where face-to-face followup is not possible)
Timepoint [1] 295231 0
At one and three months post-discharge from hospital
Secondary outcome [1] 315125 0
Quality of life using the EORTC-QLQ-C30 questionnaire
Timepoint [1] 315125 0
At one and three months post-discharge from hospital
Secondary outcome [2] 315251 0
Complications - as reported by the patient
Timepoint [2] 315251 0
At baseline, one and three months post-discharge from hospital

Eligibility
Key inclusion criteria
Curative oesophagectomy or total gastrectomy.
Have a jejunal or Naso-jejunal feeding tube placed during surgery.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-curative surgery
Limited English or cognitive ability to prevent consent
Patients requiring enteral feeding on discharge from hospital due to complications.

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)
Patients will be given Patient Information Sheet by Doctor/Nurse/Dietitian in pre-operative clinic. Once patient starts oral diet post-surgery, the ward dietitian will discuss the project with the patient to assess interest. If consented, the ward dietitian will ring Suzie Ferrie who will randomise the patient to the jejunal or oral group.
Central randomisation using sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be based on drawing a number out of a hat.
Stratfication will be based on type of surgery and nutritional status.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Basic comparison statistics.

Sample size:
For a one-sided statistical significant (a = 0.05 and 80% power) with a 2kg difference between groups (=/- 5.5 SD)
N=47
For a two-sided statistical significant (a = 0.05 and 80% power) with a 2kg difference between groups (=/- 5.5 SD)
N=60

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 3863 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 3864 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 3865 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 3866 0
St George Hospital - Kogarah
Recruitment hospital [5] 3867 0
Nepean Hospital - Kingswood
Recruitment hospital [6] 3868 0
Westmed Centre - Westmead
Recruitment hospital [7] 3869 0
Concord Repatriation Hospital - Concord
Recruitment hospital [8] 3870 0
Liverpool Hospital - Liverpool
Recruitment hospital [9] 3871 0
Mater Sydney - North Sydney
Recruitment hospital [10] 3872 0
The Alfred - Prahran
Recruitment postcode(s) [1] 9763 0
2050 - Missenden Road
Recruitment postcode(s) [2] 9766 0
2065 - Royal North Shore Hospital
Recruitment postcode(s) [3] 9810 0
2031 - Randwick
Recruitment postcode(s) [4] 9811 0
2217 - Kogarah
Recruitment postcode(s) [5] 9812 0
2751 - Penrith
Recruitment postcode(s) [6] 9813 0
2145 - Wentworthville
Recruitment postcode(s) [7] 9814 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [8] 9815 0
1871 - Liverpool
Recruitment postcode(s) [9] 9816 0
2060 - North Sydney
Recruitment postcode(s) [10] 9817 0
3004 - St Kilda Road Melbourne

Funding & Sponsors
Funding source category [1] 291411 0
Self funded/Unfunded
Name [1] 291411 0
Country [1] 291411 0
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden rd
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 290087 0
Hospital
Name [1] 290087 0
Concord Repatriation General Hospital
Address [1] 290087 0
Hospital Rd
Concord Repatriation Hospital
NSW 2139
Country [1] 290087 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292960 0
Sydney Local health District (RPA)
Ethics committee address [1] 292960 0
Ethics committee country [1] 292960 0
Australia
Date submitted for ethics approval [1] 292960 0
27/05/2015
Approval date [1] 292960 0
Ethics approval number [1] 292960 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 487 487 0 0
/AnzctrAttachments/368690-Study synpopsis.docx
Attachments [2] 488 488 0 0
/AnzctrAttachments/368690-Study Design.docx

Contacts
Principal investigator
Name 57818 0
Dr Sharon Carey
Address 57818 0
Nutrition and Dietetics Department
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050
Country 57818 0
Australia
Phone 57818 0
+612 95157863
Fax 57818 0
Email 57818 0
sharon.carey@sswahs.nsw.gov.au
Contact person for public queries
Name 57819 0
Sharon Carey
Address 57819 0
Nutrition and Dietetics Department
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050
Country 57819 0
Australia
Phone 57819 0
+612 95157863
Fax 57819 0
Email 57819 0
sharon.carey@sswahs.nsw.gov.au
Contact person for scientific queries
Name 57820 0
Sharon Carey
Address 57820 0
Nutrition and Dietetics Department
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050
Country 57820 0
Australia
Phone 57820 0
+612 95157863
Fax 57820 0
Email 57820 0
sharon.carey@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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Purpose: Following major upper gastrointestinal su... [More Details]
Conference abstractNo Still to be confirmed

Documents added automatically
No additional documents have been identified.