ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Oesophagectomy

Total gastrectomy

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Oral and Gastrointestinal

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]

Treatment: Other

Intervention code [2]

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]

Weight (reported in kilograms) - using calibrated scales (and patient recall over the phone where face-to-face followup is not possible)

Timepoint [1]

At one and three months post-discharge from hospital

Secondary outcome [1]

Quality of life using the EORTC-QLQ-C30 questionnaire

Timepoint [1]

At one and three months post-discharge from hospital

Secondary outcome [2]

Complications - as reported by the patient

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

Royal North Shore Hospital - St Leonards

Recruitment hospital [3]

Prince of Wales Hospital - Randwick

Recruitment hospital [4]

St George Hospital - Kogarah

Recruitment hospital [5]

Nepean Hospital - Kingswood

Recruitment hospital [6]

Westmed Centre - Westmead

Recruitment hospital [7]

Concord Repatriation Hospital - Concord

Recruitment hospital [8]

Liverpool Hospital - Liverpool

Recruitment hospital [9]

Mater Sydney - North Sydney

Recruitment hospital [10]

The Alfred - Prahran

Recruitment postcode(s) [1]

2050 - Missenden Road

Recruitment postcode(s) [2]

2065 - Royal North Shore Hospital

Recruitment postcode(s) [3]

2031 - Randwick

Recruitment postcode(s) [4]

2217 - Kogarah

Recruitment postcode(s) [5]

2751 - Penrith

Recruitment postcode(s) [6]

2145 - Wentworthville

Recruitment postcode(s) [7]

2139 - Concord Repatriation Hospital

Recruitment postcode(s) [8]

1871 - Liverpool

Recruitment postcode(s) [9]

2060 - North Sydney

Recruitment postcode(s) [10]

3004 - St Kilda Road Melbourne

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Royal Prince Alfred Hospital

Address

Missenden rd
Camperdown
NSW 2050

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Concord Repatriation General Hospital

Address [1]

Hospital Rd
Concord Repatriation Hospital
NSW 2139

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Sydney Local health District (RPA)

Ethics committee address [1]

Royal Prince Alfred Hospital
Missenden Rd
Camperdown 
NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/05/2015

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The aim of this study is to assess the impact of providing 900 calories from enteral feeding versus oral supplementation for the first month following discharge, for patients who have undergone oesophageal or total gastrectomy surgery.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/368690-Study synpopsis.docx

Attachments [2]

/AnzctrAttachments/368690-Study Design.docx

Contacts

Principal investigator

Name

Dr Sharon Carey

Address

Nutrition and Dietetics Department
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050

Country

Australia

Phone

+612 95157863

Fax

[email protected]

Contact person for public queries

Name

Sharon Carey

Address

Nutrition and Dietetics Department
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050

Country

Australia

Phone

+612 95157863

Fax

[email protected]

Contact person for scientific queries

Name

Sharon Carey

Address

Nutrition and Dietetics Department
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050

Country

Australia

Phone

+612 95157863

Fax

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Purpose: Following major upper gastrointestinal su... [More Details]
Conference abstract	No		Still to be confirmed

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically