Effect of a Perioperative Smoking Cessation Program on Smoking Cessation/Reduction and Perioperative Complications
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|ClinicalTrials.gov Identifier: NCT01260233|
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : August 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Smoking Tobacco Use||Other: Smoking cessation program||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||168 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of a Perioperative Smoking Cessation Program on Rates of Smoking Cessation/Reduction and Perioperative Complications: a Randomized Clinical Trial.|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||August 2013|
No Intervention: Control
No intervention. Patients will receive standard of care.
Experimental: Smoking cessation program
Receives smoking cessation program
Other: Smoking cessation program
Smoking cessation program includes:
- 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.
- smoking cessation/reduction [ Time Frame: day of surgery ]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.
- Intraoperative complications and immediate post-operative complications [ Time Frame: day of surgery ]
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)
- Time until PACU readiness for discharge / actual time in PACU [ Time Frame: day of surgery ]
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.
- Unanticipated hospital admission [ Time Frame: day of surgery ]Patient booked as one-day stay, but later admitted to inpatient ward.
- Hospital length of stay [ Time Frame: until hospital discharge ]For inpatients only, the time from admission to surgical daycare until the patient is discharged home from the hospital.
- Smoking cessation at 12 months [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260233
|St. Joseph's Health Care|
|London, Ontario, Canada, N6A 4V2|
|Principal Investigator:||Philip Jones, MD, FRCPC||University of Western Ontario, Canada|