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

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

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.
OriginalsprogEngelsk
Artikelnummer441
TidsskriftTrials
Vol/bind16
Antal sider8
ISSN1745-6215
DOI
StatusUdgivet - 2015

Bibliografisk note

Faculty of Health Sciences, University of Copenhagen 0 441 26438129

Emneord

  • Randomized clinical trial Gold Standard Program Smoking cessation Postoperative complications Peripheral vascular surgery GOLD STANDARD PROGRAM POSTOPERATIVE COMPLICATIONS GENERAL-ANESTHESIA INTERVENTION SMOKERS ABSTINENCE INFECTION NICOTINE OUTCOMES REPAIR

Citer dette

Kehlet, M. ; Heesemann, Sabine ; Tonnesen, H. ; Schroeder, T. V. / Perioperative smoking cessation in vascular surgery : challenges with a randomized controlled trial. I: Trials. 2015 ; Bind 16.
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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.",
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Perioperative smoking cessation in vascular surgery : challenges with a randomized controlled trial. / Kehlet, M.; Heesemann, Sabine; Tonnesen, H.; Schroeder, T. V.

I: Trials, Bind 16, 441, 2015.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Perioperative smoking cessation in vascular surgery

T2 - challenges with a randomized controlled trial

AU - Kehlet, M.

AU - Heesemann, Sabine

AU - Tonnesen, H.

AU - Schroeder, T. V.

N1 - Faculty of Health Sciences, University of Copenhagen 0 441 26438129

PY - 2015

Y1 - 2015

N2 - 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.

AB - 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.

KW - Randomized clinical trial Gold Standard Program Smoking cessation Postoperative complications Peripheral vascular surgery GOLD STANDARD PROGRAM POSTOPERATIVE COMPLICATIONS GENERAL-ANESTHESIA INTERVENTION SMOKERS ABSTINENCE INFECTION NICOTINE OUTCOMES REPA

U2 - 10.1186/s13063-015-0965-x

DO - 10.1186/s13063-015-0965-x

M3 - Journal article

C2 - 26438129

VL - 16

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 441

ER -