Preoperative Smoking Cessation in Patients Undergoing Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2029-09-30

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.

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Throughout the study patient data is collected in the electronic health record (LUKiS) in an uncoded manner. Allocation will be blinded. At the end of the study the LUKiS reporting team will generate a report, which will include all study data in a de-identified form. The analysis of the report with the pseudonymized data will be performed by the project statistician.

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

Intensive preoperative smoking cessation counselling

Intervention Type BEHAVIORAL

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

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 head and neck surgery
* Date of surgery \>2 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No