NCT05192837

Preoperative Smoking Cessation in Patients Undergoing Surgery

Preoperative Smoking Cessation Program in Patients Undergoing Intermediate to High-risk Surgery: a Randomized, Single-blinded, Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Luzerner Kantonsspital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking Cessation
• Smoking Reduction
• Surgery--Complications
• Surgery
• Cancer
• Postoperative Complications
• Perioperative Complication
• Smoking
• Abdominal Cancer
• Thoracic Cancer
• Urologic Cancer
• Gynecologic Cancer
• Head and Neck Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Intensive preoperative smoking cessation counselling	The study intervention consists of an interview by a Tabacco Treatment Specialist (TSS) 4 weeks before surgery with individual counselling and offered nicotine substitution. The intervention meeting is based on the Chronic Care Model (CCM) to improve quality of ambulatory care. In brief, the intervention includes: * Informative content about advantages of smoking cessation * Scheduling service for a motivational interview by a TSS in office to implement a treatment plan * For participants willing to quit smoking a preoperative quit day will be scheduled after the first intervention meeting 2-3 weeks before surgery * Patients will be encouraged by a TSS to use nicotine replacement. Bupropion or Vareniclin will be provided on an individual basis * TSS will schedule repeated follow-up meetings to support smoking abstinence or nicotine reduction before and after surgery for all patients

Timeline

• Start date: 2022-09-02
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-01-14
• Last updated: 2026-02-27

Locations

1 site across 1 country: Switzerland