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Smoking Cessation and Postoperative Complications

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Karolinska Institutet.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00533000
First received: September 19, 2007
Last updated: June 10, 2008
Last verified: September 2007
History of Changes

September 19, 2007
June 10, 2008
January 2004
Not Provided
Frequency of any postoperative complication [ Time Frame: 1 month ]
Frequency of postoperative complications [ Time Frame: 1-12 months ]
Complete list of historical versions of study NCT00533000 on ClinicalTrials.gov Archive Site
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 ]
smoking cessation rates, level of pain, quality of life, thioredoxin reductase, Il-1, Il-6, TNFa [ Time Frame: 1-12 months ]
Not Provided
Not Provided
 
Smoking Cessation and Postoperative Complications
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Postoperative Complications
  • Randomized
  • Prevention
  • Smoking Cessation
Procedure: Smoking cessation
Weekly smoking cessation by professional counseling and nicotine substitute on request
  • Experimental: A
    Smoking cessation
    Intervention: Procedure: Smoking cessation
  • No Intervention: B
Lindström D, Azodi OS, Wladis A, Tønnesen H, Linder S, Nåsell H, Ponzer S, Adami J. Effects of a perioperative smoking cessation intervention on postoperative complications: a randomized trial. Ann Surg. 2008 Nov;248(5):739-45.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
584
January 2008
Not Provided

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.
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00533000
03-214
No
Not Provided
Karolinska Institutet
Not Provided
Principal Investigator: Johanna Adami, MD Karolinska Institutet
Karolinska Institutet
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP