Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Mette Kehlet Flamand, Rigshospitalet, Denmark Identifier:
First received: October 27, 2011
Last updated: November 9, 2011
Last verified: November 2011

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:

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


Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01469091

Contact: Mette K Flamand, Dr. +45 35 45 25 86

Vascular Clinic RK, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Mette K Flamand, Dr.    +45 35 45 25 86   
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 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
Cardiovascular Diseases
Pathologic Processes processed this record on February 25, 2015