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Trial registered on ANZCTR


Registration number
ACTRN12606000364572
Ethics application status
Approved
Date submitted
15/09/2005
Date registered
22/08/2006
Date last updated
22/08/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of smoking on the surgical patient.
Scientific title
A randomised trial of the effectiveness of opportunistic interventions among patients undergoing elective surgery on smoking cessation.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco dependence 1333 0
Condition category
Condition code
Mental Health 1421 1421 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention arms receive either a single phone call informing them that the hospital is a smoke free environment and advising them of the desirability of quitting smoking preoperatively; or a combination of individual counselling and nicotine replacement therapy and are seen weekly for 6 weeks and fortnightly for 4 weeks (ie 8 intervention sessions in total).
Intervention code [1] 626 0
None
Comparator / control treatment
Participants in the control arm receive no intervention.
Control group
Active

Outcomes
Primary outcome [1] 1942 0
Smoking
Timepoint [1] 1942 0
At Date of Surgery, and 6 weeks, 3 months and 6 months post surgery
Secondary outcome [1] 3403 0
Nil
Timepoint [1] 3403 0

Eligibility
Key inclusion criteria
Nicotine dependence and nicotine tolerance of > 5 cigarettes/day (Fagerstrom test); not currently on NRT; not pregnant/breast feeding; ETOH at recommended safe levels; Social Environment suitable for follow up; not active or unstable medical psychiatric condition; able to meet attendance requirements for study; able and willing to give informed consent; first intervention not < 5 days to DOS; English that does not require an interpreter service, will be given a general anaesthetic.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Central randomisation using tamper-proof envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Identical envelopes containing group allocation randomly selected from a box
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
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)

Funding & Sponsors
Funding source category [1] 1553 0
Hospital
Name [1] 1553 0
The Langton Centre
Address [1] 1553 0
Country [1] 1553 0
Australia
Primary sponsor type
Hospital
Name
The Langton Centre
Address
Country
Australia
Secondary sponsor category [1] 1366 0
None
Name [1] 1366 0
Nil
Address [1] 1366 0
Country [1] 1366 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2984 0
Prince of Wales Hospital
Ethics committee address [1] 2984 0
Ethics committee country [1] 2984 0
Australia
Date submitted for ethics approval [1] 2984 0
Approval date [1] 2984 0
Ethics approval number [1] 2984 0

Summary
Brief summary
All hospitals in NSW are working towards becoming “Smoke Free Environments”. Patients are no longer be able to smoke in hospital. The study aims to analyse: -
The effectiveness of opportunistic intervention in smokers about to undergo surgery; Perioperative effects (physiological and physical) of short notice cessation of smoking up to six weeks prior to surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36309 0
Address 36309 0
Country 36309 0
Phone 36309 0
Fax 36309 0
Email 36309 0
Contact person for public queries
Name 9815 0
Ms. Mary-Louise White
Address 9815 0
Prince Of Wales Hospital
Randwick NSW 2031
Country 9815 0
Australia
Phone 9815 0
+61 2 93822791
Fax 9815 0
Email 9815 0
whitem@sesiahs.nsw.gov.au
Contact person for scientific queries
Name 743 0
Ms. Mary-Louise White
Address 743 0
Prince Of Wales Hospital
Randwick NSW 2031
Country 743 0
Australia
Phone 743 0
+61 2 93822791
Fax 743 0
Email 743 0
whitem@sesiahs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary