Effect of a Brief Preoperative Smoking Intervention on Postoperative Complications in Women Undergoing Breast Cancer Surgery: A Randomised Clinical Trial
Smokers are at greater risk of developing postoperative complications. The connection
between smoking and cardiovascular and pulmonary disease is furthermore well documented.
Smoking cessation 6 weeks before orthopaedic surgery significantly reduces the risk of
developing postoperative complications. However, smoking cessation for an even shorter
period may theoretically have similar effects on postoperative complications.
Intensive smoking intervention programmes increase long-term smoking cessation rates
significantly. Little evidence is available on the efficacy of brief smoking intervention
programmes for newly diagnosed cancer patients.
This study therefore aims to examine the effect of a brief smoking intervention on
postoperative complications and long-term smoking cessation rates in women undergoing breast
cancer surgery.
The study is a randomised clinical trial in which study participants are randomised by block
randomisation to either standard care (control group) or a brief preoperative smoking
intervention (intervention group). Patients in the intervention group are counselled to
comply with an intended perioperative smoking cessation period of 13 days.
The intervention and control groups will be compared up to 12 months postoperatively in
regard to frequency of postoperative complications and smoking cessation rates.
Additionally, experienced stress and nicotine withdrawal symptoms during the perioperative
smoking cessation period will be compared between the groups.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Postoperative complications requiring treatment
6 months postoperatively
No
Hanne Tønnesen, MD, PhD
Study Chair
WHO Collaborating Centre for Evidence-Based Health Promotion Hospitals
Denmark: The Regional Committee on Biomedical Research Ethics
KA-20060007
NCT00299117
April 2006
December 2008
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