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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
  Purpose

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 Intervention
Postoperative Complications
Randomized
Prevention
Smoking Cessation
 Procedure: Smoking cessation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Short Term Perioperative Smoking Cessation and the Effect on Postoperative Complications. A Randomized Clinical Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 584
Study Start Date: January 2004
Estimated Study Completion Date: January 2008
Arms Assigned Interventions
Experimental: A
Smoking cessation
 Procedure: Smoking cessation
Weekly smoking cessation by professional counseling and nicotine substitute on request
No Intervention: B

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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533000

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

No publications provided by Karolinska Institutet

Additional 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
Study First Received: September 19, 2007
Last Updated: June 10, 2008
Health Authority: Sweden: Swedish National Council on Medical Ethics

Additional relevant MeSH terms:
Postoperative Complications
Smoking
Pathologic Processes
Habits

ClinicalTrials.gov processed this record on May 19, 2013