Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000066482
Ethics application status
Approved
Date submitted
26/06/2006
Date registered
22/01/2007
Date last updated
20/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Steroids and colonic surgery
Scientific title
The influence of pre-operative dexamethasone on post operative recovery and fatigue in patients undergoing elective colonic resection
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing elective colonic resection/surgery 1557 0
Condition category
Condition code
Oral and Gastrointestinal 1657 1657 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8 mg of intravenous dexamethasone 90 minutes prior to incision
Intervention code [1] 1165 0
Prevention
Comparator / control treatment
Placebo (saline 90 minutes prior to incision)
Control group
Placebo

Outcomes
Primary outcome [1] 2292 0
Fatigue
Timepoint [1] 2292 0
Pre-op and days 1, 2, 3, 7, 30, 60, 90
Primary outcome [2] 2293 0
Local and plasma cytokine concentration
Timepoint [2] 2293 0
Morning of day 1
Primary outcome [3] 2294 0
Nausea and vomiting
Timepoint [3] 2294 0
Pre-op and days 1, 2 and 3
Primary outcome [4] 2295 0
Pain
Timepoint [4] 2295 0
Pre-op and days 1,2 and 3
Primary outcome [5] 2296 0
Return to normal activity
Timepoint [5] 2296 0
Assessed at days 3, 7, 30, 60 and 90
Secondary outcome [1] 3999 0
Sleep
Timepoint [1] 3999 0
Pre-op and days 1,2 and 3
Secondary outcome [2] 4000 0
Appetite
Timepoint [2] 4000 0
Pre-op and days 1,2 and 3
Secondary outcome [3] 4001 0
Anxiety
Timepoint [3] 4001 0
Pre-op and days 1,2 and 3

Eligibility
Key inclusion criteria
Age 18 yrs and overGender : male and female
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Sensitivity to Dexamethasone or any contraindication to use of dexamethasone, long term steroid useInclusion: colonic surgery

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes containing coded numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
subjects and assesors (the medical team and the investigators) will be blinded as to which treatment the patient is recieving pre-operatively
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 363 0
New Zealand
State/province [1] 363 0

Funding & Sponsors
Funding source category [1] 1803 0
Charities/Societies/Foundations
Name [1] 1803 0
Auckland Medical Research Foundation
Country [1] 1803 0
New Zealand
Funding source category [2] 1804 0
Government body
Name [2] 1804 0
Health Research Council of New Zealand
Country [2] 1804 0
New Zealand
Primary sponsor type
Individual
Name
Associate Professor Andrew Hill
Address
Country
Secondary sponsor category [1] 1624 0
Individual
Name [1] 1624 0
Dr Kamran Zargar
Address [1] 1624 0
Department of Surgery University of Auckland Middlemore Hospital PO Box 93311 Otahuhu Auckland
Country [1] 1624 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3369 0
Middlemore hospital
Ethics committee address [1] 3369 0
Ethics committee country [1] 3369 0
New Zealand
Date submitted for ethics approval [1] 3369 0
Approval date [1] 3369 0
Ethics approval number [1] 3369 0
NTY/06//03/020

Summary
Brief summary
Fatigue is a common and significant problem after major colonic surgery. It is thought that one cause of this fatigue is the production of inflammatory mediators, including cytokines, in the peritoneal cavity. It is known that the production of cytokines can be decreased by the use of steroids. Thus, in order to decrease fatigue after surgery, consecutive patients undergoing major colonic surgery will be randomised to 2 groups. One will receive 8 mg of preoperative Dexamethasone (intervention group) and the other will receive saline (Placebo group). We will measure fatigue, pain, nausea and vomiting scores and measures of functional recovery after surgery in order to assess that impact of the preoperative steroid.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35536 0
Address 35536 0
Country 35536 0
Phone 35536 0
Fax 35536 0
Email 35536 0
Contact person for public queries
Name 10354 0
Assoc. Prof Andrew G. Hill
Address 10354 0
Department of Surgery
University of Auckland
Middlemore Hospital
PO Box 93311 Otahuhu Auckland
Country 10354 0
New Zealand
Phone 10354 0
+64 9 276 0000 ext 8424
Fax 10354 0
+64 9 2679482
Email 10354 0
ahill@middlemore.co.nz
Contact person for scientific queries
Name 1282 0
Dr Kamran Zargar Shoshtari
Address 1282 0
Department of Surgery
University of Auckland
Middlemore Hospital
PO Box 93311 Otahuhu Auckland
Country 1282 0
New Zealand
Phone 1282 0
+64 9 2760000 ext 2100
Fax 1282 0
+64 9 2679482
Email 1282 0
kamran.zargar@gmail.com

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.