Preoperative Smoking Cessation in Patients Undergoing Surgery

Not Applicable

Recruiting

• Conditions: Smoking; Cancer; Perioperative Complication; Gynecologic Cancer; Head and Neck Cancer; Surgery; Urologic Cancer; Surgery--Complications; Abdominal Cancer; Thoracic Cancer
• Interventions: Behavioral: Intensive preoperative smoking cessation counselling

• Registration Number: NCT05192837
• Lead Sponsor: Luzerner Kantonsspital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-01
• Study First Submitted QC: 2022-01-01
• Study First Posted: 2022-01-14
• Study Start: 2022-04-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-18
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

• Patient listed for intermediate or high-risk surgery (Appendix 2) [20] at the Kantonsspital of Lucerne
• Patient undergoing surgery in one of the following departments: Abdominal surgery, thoracic surgery, urology, gynaecology, vascular surgery or head and neck surgery
• Date of surgery >4 weeks after date of listing for surgery or discussion by tumor board
• 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

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Exclusion Criteria

• Plastic surgery
• Consumption of illegal drugs
• Alcohol dependency defined as preexisting alcohol related disorders (eg. alcoholic psychosis, Alcohol abuse, Alcohol polyneuropathy, degeneration of nervous system due to alcohol, Alcoholic myopathy, Alcoholic liver disease)
• Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Intensive preoperative smoking cessation counselling	The study intervention consists of a smoking cessation counselling meeting by a Tabacco Treatment Specialist (TSS) 4 weeks before surgery. The goal of this first intervention meeting is to implement an individual treatment plan for preoperative smoking cessation.

Primary Outcome Measures

Name	Time	Method
Comprehensive Complication Index (CCI)	within a 90 days postoperative time period	The primary endpoint is the Comprehensive Complication Index (CCI) within 90 days of surgery. The CCI is calculated as the sum of all Clavien-Dindo complications that are weighted for their severity (multiplication of the median preference values from patients and physicians). The final formula yields a continuous scale that ranks the cumulative burden from any combination of complications from 0 to 100 with higher values indicating a higher cumulative burden in a single patient. As a composite complication score, the CCI has the advantage of reflecting the overall burden of the postoperative course that affects the health of patients and their quality of life. In addition, the CCI is a powerful endpoint in trials, as it allows sample size up to nine times lower compared with traditional morbidity endpoints.

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	perioperative	Days of hospital stay for planned surgery
Smoking abstinence	within a one year postoperative time period	Number of patients who successfully quit smoking
Costs of hospital stay	perioperative	Costs of hospital stay for planned surgery
Mental health	one week preoperative	The outcome is measured using the Hospital anxiety and depression scale (HADS) before surgery. The score ranges from 0 to 42 with higher values indicating a higher probability of a mood disorder.
Transtheoretical Model	preoperative	Stage of the Transtheoretical Model of behaviour change
Readmission rate	within a 90 days postoperative time period	Readmission rates for in-patient hospital stay after surgery
Smoking reduction	within a one year postoperative time period	Decrease or increase of daily nicotine consumption
IMC/ICU admission	perioperative	unplanned postoperative intermediate care or intensive care unit admission
Quality of life Short Form Survey	within a one year postoperative time period	The outcome is measured using the 36-Item Short Form Survey (SF-36). The score ranges from 0 to 100 with higher values indicating a more favorable health state.

Trial Locations

Locations (1)

LUKS; 🇨🇭 Luzern, Switzerland