Tobacco's Impact on Postoperative Complications in Acute Surgery

NCT ID: NCT01469091

Last Updated: 2015-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Smoking intervention, Nicotine replacement therapy.

Group Type ACTIVE_COMPARATOR

Smoking intervention.

Intervention Type BEHAVIORAL

Nicotine replacement therapy and meetings with nurse specialized in smoking intervention.

Controlgroup

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Smoking intervention.

Nicotine replacement therapy and meetings with nurse specialized in smoking intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* acute admittance in a vascular department
* current smoker
* surgery within 7 days
* informed/written consent

Exclusion Criteria

* alcohol intake \> 35 units pr. week
* dementia or mental disease
* \> 90 years
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Mette Kehlet

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vascular Clinic RK, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 26438129 (View on PubMed)

Other Identifiers

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Roc-2010

Identifier Type: -

Identifier Source: org_study_id

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