Preoperative Smoking Cessation in Patients Undergoing Surgery

Last updated: March 3, 2025
Sponsor: Luzerner Kantonsspital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Head And Neck Cancer

Surgery

Nasopharyngeal Cancer

Treatment

Intensive preoperative smoking cessation counselling

Clinical Study ID

NCT05192837
2021-8131
  • Ages > 18
  • All Genders

Study Summary

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 lack of time and training of surgeons and anesthesiologists. The investigators 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 preoperative smoking cessation program improves outcomes in smokers undergoing intermediate to high-risk surgery. The primary objective is to compare complications between patients with an institutional multifaceted smoking cessation intervention starting four 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 length of hospital stay, cost of hospital stay, smoking abstinence, reduction in nicotine consumption.

Methods: The present study is a single center, randomized trial with two parallel groups of smokers scheduled for surgery comparing surgery alone and surgery with preoperative smoking cessation. The investigators plan to randomize 251 patients. The primary endpoint is the Comprehensive Complication Index up to a 90-day postoperative period. The secondary endpoints include comparison of smoking abstinence, quality of life, mental health, length of stay, costs of care and difference in hospital reimbursement between the two groups.

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient listed for intermediate or high-risk surgery at the Kantonsspital of Lucerne

  • Patient undergoing surgery in one of the following departments: Abdominal surgery,thoracic surgery, cardiac surgery, urology, gynaecology, vascular surgery or headand neck surgery

  • Date of surgery >2 weeks after date of listing for surgery or discussion by tumorboard

  • Current smokers, defined as daily smoking of at least one cigarette, cigar or pipe

  • Age over 18 years

  • Able to give signed written informed consent

Exclusion

Exclusion Criteria:

  • Plastic surgery

  • Consumption of illegal drugs

  • Alcohol dependency defined as preexisting alcohol related disorders (eg. alcoholicpsychosis, Alcohol abuse, Alcohol polyneuropathy, degeneration of nervous system dueto alcohol, Alcoholic myopathy, Alcoholic liver disease)

  • Inability to follow the procedures of the study, e.g., due to language problems,psychological disorders, dementia

Study Design

Total Participants: 251
Treatment Group(s): 1
Primary Treatment: Intensive preoperative smoking cessation counselling
Phase:
Study Start date:
August 01, 2022
Estimated Completion Date:
September 30, 2029

Connect with a study center

  • LUKS

    Luzern, 6000
    Switzerland

    Active - Recruiting

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