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Effect of a Perioperative Smoking Cessation Program on Smoking Cessation/Reduction and Perioperative Complications

NCT ID: NCT01260233

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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

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Smoking Tobacco Use

Keywords

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smoking cessation complications cigarettes preoperative perioperative surgery education nicotine replacement therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Control

No intervention. Patients will receive standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Smoking cessation program

Receives smoking cessation program

Group Type EXPERIMENTAL

Smoking cessation program

Intervention Type OTHER

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

Interventions

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Smoking cessation program

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

Intervention Type OTHER

Other Intervention Names

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nicoderm transdermal nicotine replacement therapy nicotine replacement patch

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Western Ontario, Canada

OTHER

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Philip Jones

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip Jones, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

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St. Joseph's Health Care

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 25695576 (View on PubMed)

Other Identifiers

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17342

Identifier Type: OTHER

Identifier Source: secondary_id

R-10-476

Identifier Type: -

Identifier Source: org_study_id