Preoperative smoking cessation program in patients undergoing intermediate to high-risk surgery: a randomized, single-blinded, controlled, superiority trial

Christian D Fankhauser, Andres Affentranger, Beatrice Cortonesi, Urs Jeker, Markus Gass, Fabrizio Minervini, Georg Jung, Corina Christmann, Christine Brambs, Milo A Puhan, Ulrike Held, Christian D Fankhauser, Andres Affentranger, Beatrice Cortonesi, Urs Jeker, Markus Gass, Fabrizio Minervini, Georg Jung, Corina Christmann, Christine Brambs, Milo A Puhan, Ulrike Held

Abstract

Background: At present, effectively implementing smoking cessation programs in the health care system constitutes a major challenge. A unique opportunity to initiate smoking cessation focuses on smokers scheduled for surgery. These patients are not only highly motivated to quit smoking but also likely to benefit from a reduction in postoperative complications which may translate into a decrease of costs. Nevertheless, surgical patients are not routinely informed about the benefits of preoperative smoking cessation. Potential reasons for this missed opportunity may be the lack of time and training of surgeons and anaesthesiologists. We therefore aim to analyse the impact of a preoperative high-intensity smoking cessation intervention on surgical complications up to a 90-day postoperative period in patients of various surgical disciplines. The hypothesis is that a preoperative smoking cessation program improves outcomes in smokers undergoing intermediate to high-risk surgery.

Methods: The present study is a single-centre, randomized trial with two parallel groups of smokers scheduled for surgery comparing surgery alone and surgery with preoperative smoking cessation. We plan to randomize 251 patients. The primary objective is to compare complications between patients with an institutional multifaceted smoking cessation intervention starting 4 weeks before surgery compared to patients in the advice-only group (control group) within a 90-day postoperative period. The primary endpoint is the Comprehensive Complication Index (CCI®) within 90 days of surgery. Secondary outcomes include the length of hospital stay, cost of care, quality of life, smoking abstinence, and reduction in nicotine consumption.

Discussion: The hypothesis is that a preoperative smoking cessation program improves outcomes in smokers undergoing surgery.

Trial registration: BASEC #2021-02004; ClinicalTrials.gov: NCT05192837 . Registered on January 14, 2022.

Keywords: Complications; Randomized controlled trial; Smoking cessation; Surgery.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Participant timeline. ICF, informed consent form; NicAlert, nicotine saliva test

References

    1. Swiss Federal Statistical Office. Swiss Health Survey 2017. (Accessed 12 May 2022).
    1. Christopher Bullen CH, Laugesen M, McRobbie H, Parag V, Williman J, Walker N. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet. 2013;382:1629–1637. doi: 10.1016/S0140-6736(13)61842-5.
    1. Hajek P, Phillips-Waller A, Przulj D, Pesola F, Myers Smith K, Bisal N, et al. A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy. N Engl J Med. 2019;380:629–637. doi: 10.1056/NEJMoa1808779.
    1. Lee SM, Landry J, Jones PM, Buhrmann O, Morley-Forster P. The Effectiveness of a Perioperative Smoking Cessation Program: A Randomized Clinical Trial. Anesth Analg. 2013;117:605–613. doi: 10.1213/ANE.0b013e318298a6b0.
    1. Møller AM, Villebro N, Pedersen T, Tønnesen H. Effect of preoperative smoking intervention on postoperative complications: a randomised clinical trial. Lancet. 2002;359:114–117. doi: 10.1016/S0140-6736(02)07369-5.
    1. Lindström D, Sadr Azodi O, Wladis A, Tønnesen H, Linder S, Nåsell H, et al. Effects of a perioperative smoking cessation intervention on postoperative complications: a randomized trial. Ann Surg. 2008;248:739–745. doi: 10.1097/SLA.0b013e3181889d0d.
    1. Thomsen T, Villebro N, Møller AM. Interventions for preoperative smoking cessation. Cochrane Database Syst Rev. 2014;2014(3):CD002294. 10.1002/14651858.CD002294.pub4.
    1. Cornuz J, Humair JP, Seematter L, Stoianov R, van Melle G, Stalder H, et al. Efficacy of resident training in smoking cessation: a randomized, controlled trial of a program based on application of behavioral theory and practice with standardized patients. Ann Intern Med. 2002;136:429–437. doi: 10.7326/0003-4819-136-6-200203190-00006.
    1. Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013;258:1–7. doi: 10.1097/SLA.0b013e318296c732.
    1. Copeland GP, Jones D, Walters M. POSSUM: A scoring system for surgical audit. Br J Surg. 2005;78:355–360. doi: 10.1002/bjs.1800780327.
    1. Wagner EH, Austin BT, Von Korff M. Improving outcomes in chronic illness. Manag Care Q. 1996;4:12–25.
    1. Wagner EH, Austin BT, Von Korff M. Organizing care for patients with chronic illness. Milbank Q. 1996;74:511–544. doi: 10.2307/3350391.
    1. Coleman K, Austin BT, Brach C, Wagner EH. Evidence On The Chronic Care Model In The New Millennium. Health Aff (Millwood) 2009;28:75–85. doi: 10.1377/hlthaff.28.1.75.
    1. Haas JS, Linder JA, Park ER, Gonzalez I, Rigotti NA, Klinger EV, et al. Proactive Tobacco Cessation Outreach to Smokers of Low Socioeconomic Status. JAMA Intern Med. 2015;175:218. doi: 10.1001/jamainternmed.2014.6674.
    1. Donze J, Ruffieux C, Cornuz J. Determinants of smoking and cessation in older women. Age Ageing. 2006;36:53–57. doi: 10.1093/ageing/afl120.
    1. Cornuz JJSI, Humair J-P. Ärztliche Rauchstoppberatung. Die Dokumentation für die Praxis. 3. Bern: Projekt FREI VON TABAK; 2015.
    1. Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, et al. The Clavien-Dindo Classification of Surgical Complications: Five-Year Experience. Ann Surg. 2009;250:187–196. doi: 10.1097/SLA.0b013e3181b13ca2.
    1. Slankamenac K, Nederlof N, Pessaux P, de Jonge J, Wijnhoven BP, Breitenstein S, et al. The comprehensive complication index: a novel and more sensitive endpoint for assessing outcome and reducing sample size in randomized controlled trials. Ann Surg. 2014;260:757–762. doi: 10.1097/SLA.0000000000000948.
    1. Tate JC, Schmitz JM. A proposed revision of the fagerstrom tolerance questionnaire. Addict Behav. 1993;18:135–143. doi: 10.1016/0306-4603(93)90043-9.
    1. Bullinger M, Kirchberger I, Ware J. Der deutsche SF-36 Health Survey Übersetzung und psychometrische Testung eines krankheitsübergreifenden Instruments zur Erfassung der gesundheitsbezogenen Lebensqualität. J Public Health. 1995;3:21–36. doi: 10.1007/BF02959944.
    1. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40:373–383. doi: 10.1016/0021-9681(87)90171-8.
    1. Saklad M. GRADING OF PATIENTS FOR SURGICAL PROCEDURES. Anesthesiology. 1941;2:281–284. doi: 10.1097/00000542-194105000-00004.
    1. Ordinance on Clinical Trials in Human Research (ClinO) (Accessed 12 May 2022).

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere