Tobacco's Impact on Postoperative Complications in Acute Surgery

Vascular Disease Clinical Trial

— ROC  

Official title:

Tobacco's Impact on Postoperative Complications in Acute Vascular Surgery. A Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01469091
• Other study ID #: Roc-2010
• Status: Terminated
• Phase: N/A
• First received: October 27, 2011
• Last updated: March 12, 2015
• Start date: February 2011
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 160
• Est. completion date: August 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postoperative Complications
• Vascular Disease
• Vascular Diseases

Intervention

Behavioral:
• Smoking intervention.
Nicotine replacement therapy and meetings with nurse specialized in smoking intervention.

Locations

Country	Name	City	State
Denmark	Vascular Clinic RK, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications.		After 3 months.	No
Secondary	SF-36	Patients self-assessed health status.	After 3 months.	No