Smoking Cessation and Postoperative Complications - Full Text View

Sponsored by:	Karolinska Institutet
Information provided by:	Karolinska Institutet
ClinicalTrials.gov Identifier:	NCT00533000

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

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Short Term Perioperative Smoking Cessation and the Effect on Postoperative Complications. A Randomized Clinical Trial.

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

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

Publications indexed to this study:

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.

Study ID Numbers:	03-214
Study First Received:	September 19, 2007
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00533000
Health Authority:	Sweden: Swedish National Council on Medical Ethics

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Postoperative Complications
Nicotine

Additional relevant MeSH terms:

Habits
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009