Clinical trial NCT01260233: Effect of a Perioperative Smoking Cessation Program on Smoking Cessation/Reduction and Perioperative Complications
Official title: The Effect of a Perioperative Smoking Cessation Program on Rates of Smoking Cessation/Reduction and Perioperative Complications: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Tobacco Use
Keywords: smoking cessation
complications
cigarettes
preoperative
perioperative
surgery
education
nicotine replacement therapy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
First posted: 2010-12-15
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: smoking cessation
timeFrame: date of surgery
Secondary outcomes:
measure: smoking cessation/reduction
timeFrame: day of surgery
measure: Intraoperative complications and immediate post-operative complications
timeFrame: day of surgery
measure: Time until PACU readiness for discharge / actual time in PACU
timeFrame: day of surgery
measure: Unanticipated hospital admission
timeFrame: day of surgery
measure: Hospital length of stay
timeFrame: until hospital discharge
measure: Smoking cessation at 12 months
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Philip Jones, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.