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
About this trial
This is an interventional prevention trial for Postoperative Complications
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.
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
NCT ID
NCT00533000
First Posted
September 19, 2007
Last Updated
June 10, 2008
Sponsor
Karolinska Institutet
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
Learn more about this trial
Smoking Cessation and Postoperative Complications
We'll reach out to this number within 24 hrs