SmokingNCT01260233
Effect of a Perioperative Smoking Cessation Program on Smoking Cessation/Reduction and Perioperative Complications
A study testing Smoking cessation program in people with Smoking and Tobacco Use, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether a perioperative smoking cessation program, implemented at least 3 weeks prior to elective surgery, is effective in increasing rates of smoking cessation or reduction. Intraoperative and immediate postoperative complications will also be compared. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Tobacco Use
- What is being tested?
- Smoking cessation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- smokers (defined as those that smoke at least 2 cigarettes per day and have smoked within the last 7 days)
- over age 18
- presenting to preadmission clinic at St. Joseph's Health Care at least 3 weeks prior to scheduled date of surgery
Who cannot join
- less than age 18
- poor proficiency in English language
- pregnant
- breastfeeding
- unable to consent due to severe mental illness or dementia
- actively participating in another smoking cessation trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Perioperative Smoking Cessation Program on Rates of Smoking Cessation/Reduction and Perioperative Complications: a Randomized Clinical Trial.
The purpose of this study is to determine whether a perioperative smoking cessation program, implemented at least 3 weeks prior to elective surgery, is effective in increasing rates of smoking cessation or reduction. Intraoperative and immediate postoperative complications will also be compared.
Read the detailed description
Previous studies have shown that patients have up to one-third fewer complications after surgery when they quit smoking at least several weeks before surgery. Nicotine replacement therapy (which relieves cravings for cigarettes) and support by healthcare professionals have been shown to help patients quit smoking, particularly when encountering a major health event (e.g. surgery). In addition, quitting smoking in preparation for surgery sometimes results in quitting for a longer period of time after surgery, giving these patients the health benefits of long-term smoking cessation such as reduced rates of cancer and heart disease.
The preadmission clinic at St. Joseph's Health Care, London, Ontario, is assessing how effective a new 'Stop Smoking' program is for patients preparing for surgery. The program will include brief counselling in the clinic, smoking cessation brochures, six weeks of free transdermal nicotine replacement therapy and a referral to the Canadian Cancer Society's Smokers' Helpline telephone advice line. Patients that are smokers and preparing for their elective surgery will be invited to join the study, then be assigned to a group that either participates in the program or not. These groups will then be compared in terms of success at quitting smoking and complication rates around the time of surgery.
- Conditions
- Smoking, Tobacco Use
- Being tested
- Smoking cessation program
- Keywords
- smoking cessation, complications, cigarettes, preoperative, perioperative, surgery, education, nicotine replacement therapy
- Medical subject headings
- Smoking, Tobacco Use, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation programOther
Also called nicoderm, transdermal nicotine replacement therapy, nicotine replacement patch
Smoking cessation program includes:
- brief smoking cessation counselling by preadmission nurse (less than 5 minutes)
- smoking cessation brochures
- referral to the Smokers' Helpline telephone advice line, run by the Canadian Cancer Society
- free transdermal nicotine replacement therapy for 6 weeks Smokers of 10 cigarettes per day or more receive 4 weeks of nicoderm 21mg/day, 1 week of 14mg/day and 1 week of 7mg/day Smokers of less than 10 cigarettes per day receive 4 weeks of nicoderm 14mg/day and 2 weeks of 7mg/day
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention. Patients will receive standard of care. |
| Smoking cessation program | Experimental | Receives smoking cessation program Receives: Other: Smoking cessation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking cessation
Smoking cessation is defined as exhaled carbon monoxide (CO) of equal to or less than 7ppm on the day of surgery.
Measured: date of surgery
Secondary outcomes (6)
smoking cessation/reduction
Smoking cessation/reduction by self-report. Smoking cessation defined as zero cigarettes in the 7 days before surgery (but exhaled CO > 7ppm) Reduction defined as 50% or less of initial self-report.
Measured: day of surgery
Intraoperative complications and immediate post-operative complications
Events occurring in the operating room or post-anesthetic care unit (PACU) as reported by a blinded anesthesiologist or blinded PACU nurse:
Cardiovascular complications, Respiratory complications, Other (detailed description exceeds character limits)
Measured: day of surgery
Time until PACU readiness for discharge / actual time in PACU
The time of arrival in PACU until the time the patient is deemed ready for discharge in accordance with hospital routine scoring system. The actual time spent in PACU (arrival until discharge) will also be compared.
Patients bypassing PACU (e.g. patients having only sedation transferred directly from the operating room to surgical daycare prior to discharge home) will be considered separately.
Measured: day of surgery
Unanticipated hospital admission
Patient booked as one-day stay, but later admitted to inpatient ward.
Measured: day of surgery
Hospital length of stay
For inpatients only, the time from admission to surgical daycare until the patient is discharged home from the hospital.
Measured: until hospital discharge
Smoking cessation at 12 months
Self-reported smoking zero cigarettes in the 7 days prior to phone call. Phone call will occur at any time during the 12th month after surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Responsible party
- Principal investigator, Philip Jones, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Philip Jones, MD, FRCPC, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260233
- Sponsor's protocol ID
- R-10-476
- Other IDs
- 17342
- Status last verified
- Aug 2013
- First submitted
- 13 Dec 2010
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee SM, Landry J, Jones PM, Buhrmann O, Morley-Forster P. Long-term quit rates after a perioperative smoking cessation randomized controlled trial. Anesth Analg. 2015 Mar;120(3):582-587. doi: 10.1213/ANE.0000000000000555.
PubMed 25695576
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Perioperative Smoking Cessation Program on Rates of Smoking Cessation/Reduction and Perioperative Complications: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01260233
- Acronym / sponsor ID
- R-10-476
- Conditions
- Smoking, Tobacco Use
- Keywords
- smoking cessation, complications, cigarettes, preoperative, perioperative, surgery, education, nicotine replacement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Study start
- Oct 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a perioperative smoking cessation program, implemented at least 3 weeks prior to elective surgery, is effective in increasing rates of smoking cessation or reduction. Intraoperative and immediate postoperative complications will also be compared.
Detailed description
Previous studies have shown that patients have up to one-third fewer complications after surgery when they quit smoking at least several weeks before surgery. Nicotine replacement therapy (which relieves cravings for cigarettes) and support by healthcare professionals have been shown to help patients quit smoking, particularly when encountering a major health event (e.g. surgery). In addition, quitting smoking in preparation for surgery sometimes results in quitting for a longer period of time after surgery, giving these patients the health benefits of long-term smoking cessation such as reduced rates of cancer and heart disease.
The preadmission clinic at St. Joseph's Health Care, London, Ontario, is assessing how effective a new 'Stop Smoking' program is for patients preparing for surgery. The program will include brief counselling in the clinic, smoking cessation brochures, six weeks of free transdermal nicotine replacement therapy and a referral to the Canadian Cancer Society's Smokers' Helpline telephone advice line. Patients that are smokers and preparing for their elective surgery will be invited to join the study, then be assigned to a group that either participates in the program or not. These groups will then be compared in terms of success at quitting smoking and complication rates around the time of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention. Patients will receive standard of care. |
| Smoking cessation program | Experimental | Other: Smoking cessation programReceives smoking cessation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- smokers (defined as those that smoke at least 2 cigarettes per day and have smoked within the last 7 days)
- over age 18
- presenting to preadmission clinic at St. Joseph's Health Care at least 3 weeks prior to scheduled date of surgery
Key exclusion criteria (6 listed)
- less than age 18
- poor proficiency in English language
- pregnant
- breastfeeding
- unable to consent due to severe mental illness or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation programAlso: nicoderm, transdermal nicotine replacement therapy, nicotine replacement patchSmoking cessation program includes: * brief smoking cessation counselling by preadmission nurse (less than 5 minutes) * smoking cessation brochures * referral to the Smokers' Helpline telephone advice line, run by the Canadian Cancer Society * free transdermal nicotine replacement therapy for 6 weeks Smokers of 10 cigarettes per day or more receive 4 weeks of nicoderm 21mg/day, 1 week of 14mg/day and 1 week of 7mg/day Smokers of less than 10 cigarettes per day receive 4 weeks of nicoderm 14mg/day and 2 weeks of 7mg/day | Other | Smoking cessation program |
Primary outcome
smoking cessation
Time frame: date of surgery
Smoking cessation is defined as exhaled carbon monoxide (CO) of equal to or less than 7ppm on the day of surgery.
6 secondary outcomes
smoking cessation/reduction
Time frame: day of surgery
Intraoperative complications and immediate post-operative complications
Time frame: day of surgery
Time until PACU readiness for discharge / actual time in PACU
Time frame: day of surgery
Unanticipated hospital admission
Time frame: day of surgery
Hospital length of stay
Time frame: until hospital discharge
Smoking cessation at 12 months
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
- Derived from this study: PubMed 25695576Lee SM, Landry J, Jones PM, Buhrmann O, Morley-Forster P. Long-term quit rates after a perioperative smoking cessation randomized controlled trial. Anesth Analg. 2015 Mar;120(3):582-587. doi: 10.1213/ANE.0000000000000555.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Jones, MD, FRCPC principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation program in people with Smoking and Tobacco Use, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
smoking cessation (time frame: date of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01260233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.