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Smoking Cessation and Postoperative Complications

Primary Purpose

Postoperative Complications, Randomized, Prevention

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smoking cessation
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complications

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    A

    B

    Arm Description

    Smoking cessation

    Outcomes

    Primary Outcome Measures

    Frequency of any postoperative complication

    Secondary Outcome Measures

    wound complication rate, smoking cessation rates, level of postoperative pain, quality of life, thioredoxin reductase, Il-1, Il-6, TNFa

    Full Information

    First Posted
    September 19, 2007
    Last Updated
    June 10, 2008
    Sponsor
    Karolinska Institutet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00533000
    Brief Title
    Smoking Cessation and Postoperative Complications
    Official Title
    Short Term Perioperative Smoking Cessation and the Effect on Postoperative Complications. A Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2007
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2008 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Karolinska Institutet

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Complications, Randomized, Prevention, Smoking Cessation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    584 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    Smoking cessation
    Arm Title
    B
    Arm Type
    No Intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    Smoking cessation
    Intervention Description
    Weekly smoking cessation by professional counseling and nicotine substitute on request
    Primary Outcome Measure Information:
    Title
    Frequency of any postoperative complication
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johanna Adami, MD
    Organizational Affiliation
    Karolinska Institutet
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18948800
    Citation
    Lindstrom D, Sadr Azodi O, Wladis A, Tonnesen H, Linder S, Nasell 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. doi: 10.1097/SLA.0b013e3181889d0d.
    Results Reference
    derived

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    Smoking Cessation and Postoperative Complications

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