NCT01469091

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

1.6 years

First QC Date

October 27, 2011

Last Update Submit

March 12, 2015

Conditions

Vascular Disease

Keywords

Acute admittanceCurrent smoker

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications.

    After 3 months.

Secondary Outcomes (1)

  • SF-36

    After 3 months.

Study Arms (2)

Smoking intervention, Nicotine replacement therapy.

ACTIVE COMPARATOR
Behavioral: Smoking intervention.

Controlgroup

NO INTERVENTION

Interventions

Smoking intervention.BEHAVIORAL

Nicotine replacement therapy and meetings with nurse specialized in smoking intervention.

Smoking intervention, Nicotine replacement therapy.

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute admittance in a vascular department
  • current smoker
  • surgery within 7 days
  • informed/written consent

You may not qualify if:

  • alcohol intake \> 35 units pr. week
  • dementia or mental disease
  • \> 90 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vascular Clinic RK, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 26438129DERIVED

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 27, 2011

First Posted

November 10, 2011

Study Start

February 1, 2011

Primary Completion

September 1, 2012

Study Completion

August 1, 2014

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

DK(1)