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Tobacco's Impact on Postoperative Complications in Acute Surgery (ROC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01469091
Recruitment Status : Terminated (Lack of patient inclusion)
First Posted : November 10, 2011
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Vascular Disease Behavioral: Smoking intervention.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Tobacco's Impact on Postoperative Complications in Acute Vascular Surgery. A Randomized Clinical Trial
Study Start Date : February 2011
Primary Completion Date : September 2012
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Smoking intervention, Nicotine replacement therapy. Behavioral: Smoking intervention.
Nicotine replacement therapy and meetings with nurse specialized in smoking intervention.
No Intervention: Controlgroup


Outcome Measures

Primary Outcome Measures :
  1. Postoperative complications. [ Time Frame: After 3 months. ]

Secondary Outcome Measures :
  1. SF-36 [ Time Frame: After 3 months. ]
    Patients self-assessed health status.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469091


Locations
Denmark
Vascular Clinic RK, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mette Kehlet, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01469091     History of Changes
Other Study ID Numbers: Roc-2010
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Mette Kehlet, Rigshospitalet, Denmark:
Acute admittance
Current smoker

Additional relevant MeSH terms:
Vascular Diseases
Postoperative Complications
Cardiovascular Diseases
Pathologic Processes