Postoperative ComplicationsNCT00533000
Smoking Cessation and Postoperative Complications
A study testing Smoking cessation in people with Postoperative Complications and Randomized, run by Karolinska Institutet.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Postoperative Complications, Randomized, Prevention
- What is being tested?
- Smoking cessation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - Active drug abuse or severe mental illness prohibiting compliance with the study protocol.
- Pregnancy.
- Residence outside the county of Stockholm.
About this study
Official title: Short Term Perioperative Smoking Cessation and the Effect on Postoperative Complications. A Randomized Clinical Trial.
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.
Read the 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
- Conditions
- Postoperative Complications, Randomized, Prevention, Smoking Cessation
- Being tested
- Smoking cessation
- Medical subject headings
- Postoperative Complications, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessationProcedure or surgery
Weekly smoking cessation by professional counseling and nicotine substitute on request
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Smoking cessation Receives: Procedure: Smoking cessation |
| B | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of any postoperative complication
Measured: 1 month
Secondary outcomes (1)
wound complication rate, smoking cessation rates, level of postoperative pain, quality of life, thioredoxin reductase, Il-1, Il-6, TNFa
Measured: 1-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startJan 2004
- Study completionJan 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 584 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Investigators
- Johanna Adami, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533000
- Sponsor's protocol ID
- 03-214
- Status last verified
- Sep 2007
- First submitted
- 19 Sep 2007
- Last updated
- 11 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18948800
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Perioperative Smoking Cessation and the Effect on Postoperative Complications. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT00533000
- Acronym / sponsor ID
- 03-214
- Conditions
- Postoperative Complications, Randomized, Prevention, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 584 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Jan 2008 (estimated)
- First posted
- 21 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Smoking cessationSmoking cessation |
| B | No intervention | – |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- - Active drug abuse or severe mental illness prohibiting compliance with the study protocol.
- Pregnancy.
- Residence outside the county of Stockholm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessationWeekly smoking cessation by professional counseling and nicotine substitute on request | Procedure or surgery | A |
Primary outcome
Frequency of any postoperative complication
Time frame: 1 month
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2008.
- Derived from this study: PubMed 18948800Lindstrom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanna Adami, MD principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation in people with Postoperative Complications and Randomized, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of any postoperative complication (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00533000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2008.