Perioperative smoking cessation in vascular surgery: challenges with a randomized controlled trial

M. Kehlet, Sabine Heesemann, H. Tonnesen, T. V. Schroeder

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

Background: The effect of intensive smoking cessation programs on postoperative complications has never before been assessed in soft tissue surgery when smoking cessation is initiated on the day of surgery. Methods: A single-blinded randomized clinical trial conducted at two vascular surgery departments in Denmark. The intervention group was offered the Gold Standard Program (GSP) for smoking cessation intervention. The control group was offered the departments' standard care. Inclusion criteria were patients with planned open peripheral vascular surgery and who were daily smokers. According to the power calculation a total of 144 patients were needed in the trial. Results: Due to slow patient inclusion, the trial was terminated prior to fulfilling the power calculation. Thirty-two patients were included in the trial from March 2011 to September 2012. Of these, 11 were randomized to the GSP intervention and 21 as controls. There was no difference in 30-day complication rates or 6-week abstinence rates between the two groups. Conclusions: A trial assessing the effect of smoking cessation on postoperative complications on the day of soft tissue surgery is still needed. If another trial is to be planned it must be more pragmatic with less extended inclusion criteria and conducted nationally or internationally to ensure enough patients for the trial. Trial registration: ClinicalTrials.gov (NCT01469091). Registration date: 27 October 2011.

Original languageEnglish
Article number441
JournalTrials
Volume16
Number of pages8
ISSN1745-6215
DOIs
Publication statusPublished - 5. Oct 2015

Keywords

  • Gold Standard Program
  • Peripheral vascular surgery
  • Postoperative complications
  • Randomized clinical trial
  • Smoking cessation
  • Humans
  • Middle Aged
  • Clinical Protocols
  • Male
  • Smoking/adverse effects
  • Smoking Prevention
  • Patient Selection
  • Early Termination of Clinical Trials
  • Time Factors
  • Aged, 80 and over
  • Adult
  • Female
  • Risk Factors
  • Postoperative Complications/etiology
  • Treatment Outcome
  • Preoperative Care
  • Peripheral Arterial Disease/diagnosis
  • Sample Size
  • Denmark
  • Vascular Surgical Procedures/adverse effects
  • Aged
  • Smoking Cessation

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