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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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Main Hypothesis: The multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by quit line) in the preoperative clinic is more effective than the simple preoperative smoking intervention (brief advice and provision of information about the quit lines ) in terms of short-term and long-term quit rates
Objectives: To evaluate the effectiveness and feasibility of a multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by the quit line) in the preoperative clinic to help surgical patients quit smoking perioperatively and for the long-term.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smoking cessation group | Experimental | Counselling, Pharmacotherapy and Smokers Help Line |
|
| Control group | Other | Brief informatin about quitting and smokers help line |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking cessation counselling group | Drug | The smoking-cessation program has three components; structured preoperative counseling, pharmacotherapy with varenicline for three months, and referral to the quit line (Smokers' Helpline) for proactive telephone counseling and follow up |
| Measure | Description | Time Frame |
|---|---|---|
| pre-surgery counseling for quit smoking | In order to determine the prevalence of abstinence in long-term follow up (4, 12, 24 and 52 weeks), patients will be asked the following questions:
| 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| perioperative complications | Secondary outcome measures that will be studied are as follows: The changes in the number of cigarettes consumed per day or 'stage of change' at 4, 12, 24 and 52 weeks after the initial assigned target quit date. The incidence of perioperative complications (until 30 days after surgery) as well as medication-related adverse events (and serious adverse events) will also be recorded (only those who in the smoking-cessation program). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frances Chung, FRCPC | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital, Department of Aneshtesia | Toronto | Ontario | M5T2S8 | Canada | ||
| Mount Sinai Hospital, Department of Anesthesia |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group: | Other | Interventions in the control group will be a brief advice regarding smoking cessation and provision of the quit line's information. |
|
| 3 months after surgery |
| Toronto |
| Ontario |
| Canada |
| D008722 | Methods |