Smoking Cessation and Postoperative Complications
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|ClinicalTrials.gov Identifier: NCT00533000|
Recruitment Status : Unknown
Verified September 2007 by Karolinska Institutet.
Recruitment status was: Active, not recruiting
First Posted : September 21, 2007
Last Update Posted : June 11, 2008
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Complications Randomized Prevention Smoking Cessation||Procedure: Smoking cessation||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||584 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Short Term Perioperative Smoking Cessation and the Effect on Postoperative Complications. A Randomized Clinical Trial.|
|Study Start Date :||January 2004|
|Estimated Study Completion Date :||January 2008|
Procedure: Smoking cessation
Weekly smoking cessation by professional counseling and nicotine substitute on request
|No Intervention: B|
- 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 ]
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): NCT00533000
|Principal Investigator:||Johanna Adami, MD||Karolinska Institutet|