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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
Sponsor:
Information provided by:
Karolinska Institutet

Brief Summary:
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.

Condition or disease Intervention/treatment
Postoperative Complications Randomized Prevention Smoking Cessation Procedure: Smoking cessation

Detailed 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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 584 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Smoking cessation
Procedure: Smoking cessation
Weekly smoking cessation by professional counseling and nicotine substitute on request
No Intervention: B



Primary Outcome Measures :
  1. Frequency of any postoperative complication [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Johanna Adami, MD Karolinska Institutet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00533000     History of Changes
Other Study ID Numbers: 03-214
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: June 11, 2008
Last Verified: September 2007

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes