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

This study has been terminated.
(Lack of patient inclusion)
Sponsor:
Information provided by (Responsible Party):
Mette Kehlet, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01469091
First received: October 27, 2011
Last updated: March 12, 2015
Last verified: March 2015
  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:


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
Study Completion Date: August 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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
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 ClinicalTrials.gov identifier: NCT01469091

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

No publications provided

Responsible Party: Mette Kehlet, 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: March 12, 2015
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

ClinicalTrials.gov processed this record on June 28, 2015