Back to resultsTobacco's Impact on Postoperative Complications in Acute Surgery (ROC)
Primary Purpose
Vascular Disease
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Smoking intervention.
Sponsored by
About this trial
This is an interventional prevention trial for Vascular Disease focused on measuring Acute admittance, Current smoker
Eligibility 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
Sites / Locations
- Vascular Clinic RK, Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Smoking intervention, Nicotine replacement therapy.
Controlgroup
Arm Description
Outcomes
Primary Outcome Measures
Postoperative complications.
Secondary Outcome Measures
SF-36
Patients self-assessed health status.
Full Information
NCT ID
NCT01469091
First Posted
October 27, 2011
Last Updated
March 12, 2015
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01469091
Brief Title
Tobacco's Impact on Postoperative Complications in Acute Surgery
Acronym
ROC
Official Title
Tobacco's Impact on Postoperative Complications in Acute Vascular Surgery. A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Lack of patient inclusion
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Disease
Keywords
Acute admittance, Current smoker
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Smoking intervention, Nicotine replacement therapy.
Arm Type
Active Comparator
Arm Title
Controlgroup
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Smoking intervention.
Intervention Description
Nicotine replacement therapy and meetings with nurse specialized in smoking intervention.
Primary Outcome Measure Information:
Title
Postoperative complications.
Time Frame
After 3 months.
Secondary Outcome Measure Information:
Title
SF-36
Description
Patients self-assessed health status.
Time Frame
After 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Vascular Clinic RK, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
26438129
Citation
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.
Results Reference
derived
Learn more about this trial
Tobacco's Impact on Postoperative Complications in Acute Surgery
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