Vascular DiseaseROCNCT01469091
Tobacco's Impact on Postoperative Complications in Acute Surgery
A study testing Smoking intervention. in people with Vascular Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of the study is to see whether intensive smoking intervention on the day of operation can reduce per- and postoperative complications in patients operated for acute ischaemic disease compared to control group with no intervention. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Vascular Disease
- What is being tested?
- Smoking intervention.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Aug 2014
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute admittance in a vascular department
- current smoker
- surgery within 7 days
- informed/written consent
Who cannot join
- alcohol intake > 35 units pr. week
- dementia or mental disease
- > 90 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tobacco's Impact on Postoperative Complications in Acute Vascular Surgery. A Randomized Clinical Trial
The purpose of the study is to see whether intensive smoking intervention on the day of operation can reduce per- and postoperative complications in patients operated for acute ischaemic disease compared to control group with no intervention.
- Conditions
- Vascular Disease
- Being tested
- Smoking intervention.
- Keywords
- Acute admittance, Current smoker
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking intervention.Behavioural
Nicotine replacement therapy and meetings with nurse specialized in smoking intervention.
| Study group | Role | What they receive |
|---|---|---|
| Smoking intervention, Nicotine replacement therapy. | Active comparator | Not described Receives: Behavioral: Smoking intervention. |
| Controlgroup | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications.
Measured: After 3 months.
Secondary outcomes (1)
SF-36
Patients self-assessed health status.
Measured: After 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2012
- Study completionAug 2014
Why it stopped: Lack of patient inclusion
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 Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Kehlet, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469091
- Sponsor's protocol ID
- Roc-2010
- Acronym
- ROC
- Status last verified
- Mar 2015
- First submitted
- 27 Oct 2011
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kehlet M, Heeseman S, Tonnesen H, Schroeder TV. Perioperative smoking cessation in vascular surgery: challenges with a randomized controlled trial. Trials. 2015 Oct 5;16:441. doi: 10.1186/s13063-015-0965-x.
PubMed 26438129
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco's Impact on Postoperative Complications in Acute Vascular Surgery. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01469091
- Acronym / sponsor ID
- ROC / Roc-2010
- Conditions
- Vascular Disease
- Keywords
- Acute admittance, Current smoker
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patient inclusion
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Nov 2011 (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 purpose of the study is to see whether intensive smoking intervention on the day of operation can reduce per- and postoperative complications in patients operated for acute ischaemic disease compared to control group with no intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking intervention, Nicotine replacement therapy. | Active comparator | Behavioral: Smoking intervention. |
| Controlgroup | No intervention | – |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- acute admittance in a vascular department
- current smoker
- surgery within 7 days
- informed/written consent
Key exclusion criteria (3 listed)
- alcohol intake > 35 units pr. week
- dementia or mental disease
- > 90 years
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 intervention.Nicotine replacement therapy and meetings with nurse specialized in smoking intervention. | Behavioural | Smoking intervention, Nicotine replacement therapy. |
Primary outcome
Postoperative complications.
Time frame: After 3 months.
1 secondary outcome
SF-36
Time frame: After 3 months.
Results and safety
The study was stopped early (reason given: Lack of patient inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Derived from this study: PubMed 26438129Kehlet M, Heeseman S, Tonnesen H, Schroeder TV. Perioperative smoking cessation in vascular surgery: challenges with a randomized controlled trial. Trials. 2015 Oct 5;16:441. doi: 10.1186/s13063-015-0965-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking intervention. in people with Vascular Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 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: stopped early, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Lack of patient inclusion). 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?
Postoperative complications. (time frame: After 3 months.). 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 NCT01469091, 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 17 Mar 2015.