Smoking Cessation Clinical Trial
Official title:
Short Term Perioperative Smoking Cessation and the Effect on Postoperative Complications. A Randomized Clinical Trial.
The primary aim of this study is to evaluate the effect of preoperative smoking cessation on postoperative complications among patients undergoing surgery. Secondary aims are to evaluate effect on wound complications, short and long term effects including abstinence rate, pain, quality of life and effects on the immune system.
Tobacco smokers suffers from postoperative complications after surgery more extensively than
non-smokers. Our primary aim is to study if smoking cessation four weeks prior to elective
surgery decreases the number of postoperative complications. Secondary aims is to analyse if
smoking cessation four weeks prior to elective surgery decreases wound complications,
analyse the effect on abstinence rate, effect on postoperative pain, quality of life and if
smoking cessation normalises; the immunological response to surgery.
The study is randomised, prospective, multicenter-based trial. Daily smokers are randomised
to 1. Control group (standard care) or 2. smoking cessation. Patients randomised to smoking
cessation will undergo professional motivational counselling and will receive free nicotine
substitution. The study will include elective cases that are scheduled for surgery.
Cessation starts 3-5 weeks prior to surgery. All patients are prospectively followed up for
four weeks concerning post-operative complications and for one year concerning other
outcomes. Outcome (complications) is registered by a blind observer.
Analyses will be performed by intention to treat. The intervention group is compared with
the control group and an adjustment for possible confounders will be done. There will also
be an analysis in the subgroups depending on which surgical procedure was
performed.Secondary analyses will be by protocol
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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