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

This study is currently recruiting participants.
Verified November 2011 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Mette Kehlet Flamand, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01469091
First received: October 27, 2011
Last updated: November 9, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention
Vascular Disease
 Behavioral: Smoking intervention.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Tobacco's Impact on Postoperative Complications in Acute Vascular Surgery. A Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Postoperative complications. [ Time Frame: After 3 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-36 [ Time Frame: After 3 months. ] [ Designated as safety issue: No ]
    Patients self-assessed health status.


Estimated Enrollment: 160
Study Start Date: February 2011
Arms Assigned Interventions
Active Comparator: Smoking intervention, Nicotine replacement therapy. Behavioral: Smoking intervention.
Nicotine replacement therapy and meetings with nurse specialized in smoking intervention.
No Intervention: Controlgroup

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469091

Contacts
Contact: Mette K Flamand, Dr. +45 35 45 25 86 metteflamand@dadlnet.dk

Locations
Denmark
Vascular Clinic RK, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Mette K Flamand, Dr.     +45 35 45 25 86     metteflamand@dadlnet.dk    
Principal Investigator: Mette K Flamand, Dr.            
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Mette Kehlet Flamand, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01469091     History of Changes
Other Study ID Numbers: Roc-2010
Study First Received: October 27, 2011
Last Updated: November 9, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
Acute admittance
Current smoker

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

ClinicalTrials.gov processed this record on June 13, 2013