Preoperative Smoking Cessation in Patients Undergoing Surgery (PORTICO)

Luzerner Kantonsspital

Status: Enrolling

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

Treatments: Behavioral: Intensive preoperative smoking cessation counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT05192837

2021-8131

Details and patient eligibility

About

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.

Enrollment: 251 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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251 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Intensive preoperative smoking cessation counselling

Control group

No Intervention group

Description:

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.