title: Perioperative smoking cessation in vascular surgery: challenges with a randomized controlled trial.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov ( NCT01469091 ). Registration date: 27 October 2011.
authors.affiliation: Vascular Clinic, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. mettekehlet@dadlnet.dk.|Centre for Clinical Education, University of Copenhagen and Capital Region of Denmark, Blegdamsvej 9, 2100, Copenhagen, Denmark. mettekehlet@dadlnet.dk.|Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200, Copenhagen N, Denmark. mettekehlet@dadlnet.dk.
authors.forename: Mette
authors.initials: M
authors.lastname: Kehlet
authors.affiliation: Vascular Clinic, Lillebaelt Hospital, Søndre Boulevard 29, 5000, Odense C, Denmark. sabineheesemann@gmail.com.
authors.forename: Sabine
authors.initials: S
authors.lastname: Heeseman
authors.affiliation: WHO-CC Clinical Health Promotion Centre, Bispebjerg and Frederiksberg Hospital, Nordre Fasanvej 57, 2000, Frederiksberg, Denmark. hanne.tonnesen@regionh.dk.|Clinical Health Promotion Centre, Department of Health Sciences, Lund University, Skåne University Hospital, Södra Förstadsgatan 101, 214 28, Malmö, Sweden. hanne.tonnesen@regionh.dk.
authors.forename: Hanne
authors.initials: H
authors.lastname: Tønnesen
authors.affiliation: Vascular Clinic, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. torben.schroeder@regionh.dk.|Centre for Clinical Education, University of Copenhagen and Capital Region of Denmark, Blegdamsvej 9, 2100, Copenhagen, Denmark. torben.schroeder@regionh.dk.|Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200, Copenhagen N, Denmark. torben.schroeder@regionh.dk.
authors.forename: Torben V
authors.initials: TV
authors.lastname: Schroeder
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D003718:Denmark; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000601:surgery*; D011183:Postoperative Complications / Q000209:etiology* / Q000517:prevention & control; D011300:Preoperative Care; D012307:Risk Factors; D018401:Sample Size; D012907:Smoking / Q000009:adverse effects; D016540:Smoking Cessation; D000074606:Smoking Prevention; D013997:Time Factors; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000009:adverse effects*