Preoperative Smoking Cessation in Patients Undergoing Surgery

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Behavioral: Intensive preoperative smoking cessation counselling


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomised in a 1:1 ratio to either the intervention or control group using service of the University of Graz (www.randomizer.at). Before randomisation patients will be pre-stratified for age (≤60, >60 years) and procedure (intermediate versus high-risk procedures). Both factors have been identified in a previous retrospective cohort study at our institution as risk factors for complications. For that reason, minimization, as an efficient way to control for confounding in small to moderately sized trials, will be used. Also, minimization automatically ensures concealment of random allocation since there is no pre-existing randomization list.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Behavioral: Intensive preoperative smoking cessation counselling<br>* 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<br>|
| No Intervention: Control group<br>Patients randomised to the control arm will get advice only. Their preoperative course will be as if they were not participating in this study, meaning they will receive inconsistent perioperative smoking cessation advice from nurses, surgeons, or anaesthesiologists but no further study-specific smoking cessation intervention. Importantly, participants in the control group will not be discouraged from using perioperative smoking cessation aids and can still obtain help on one's own initiative. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive Complication Index (CCI) | 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. | within a 90 days postoperative time period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Days of hospital stay for planned surgery | perioperative | 
| Costs of hospital stay | Costs of hospital stay for planned surgery | perioperative | 
| Readmission rate | Readmission rates for in-patient hospital stay after surgery | within a 90 days postoperative time period | 
| Smoking abstinence | Number of patients who successfully quit smoking | within a one year postoperative time period | 
| Smoking reduction | Decrease or increase of daily nicotine consumption | within a one year postoperative time period | 
| Mental health | 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. | one week preoperative | 
| IMC/ICU admission | unplanned postoperative intermediate care or intensive care unit admission | perioperative | 
| Transtheoretical Model | Stage of the Transtheoretical Model of behaviour change | preoperative | 
| Quality of life Short Form Survey | 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. | within a one year postoperative time period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preoperative smoking cessation, intensive smoking cessation, intermediate-risk surgery, high-risk surgery, nicotine replacement therapy, varenicline, bupropion, clavien dindo classification, comprehensive complication index, epic, electronic health record