Smoking Cessation and Postoperative Complications
This trial is active, not recruiting.
|Conditions||postoperative complications, randomized, prevention, smoking cessation|
|Start date||January 2004|
|End date||January 2008|
|Trial size||584 participants|
|Trial identifier||NCT00533000, 03-214|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Frequency of any postoperative complication
time frame: 1 month
wound complication rate, smoking cessation rates, level of postoperative pain, quality of life, thioredoxin reductase, Il-1, Il-6, TNFa
time frame: 1-12 months
Male or female participants from 18 years up to 79 years old.
Inclusion Criteria: - Active, daily tobacco smokers (> 2 cigarettes daily for at least one year prior to inclusion), 18-79 years old at the time of randomisation. - Proficiency in the Swedish language. - Oral and written consent. - Scheduled for primary inguinal hernia repair or other umbilical hernia repair or laparoscopic cholecystectomy - Scheduled for hip- or knee replacement Exclusion Criteria: - - Active drug abuse or severe mental illness prohibiting compliance with the study protocol. - Pregnancy. - Residence outside the county of Stockholm.
|Official title||Short Term Perioperative Smoking Cessation and the Effect on Postoperative Complications. A Randomized Clinical Trial.|
|Principal investigator||Johanna Adami, MD|
|Description||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|
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