PeRiopEratiVE SmokiNg CessaTion Trial

complete abstinence (smoking not more than 5 cigarettes) beginning on day 5 post randomization and lasting until the assessment at 6 months post-randomization with biochemical verification for those who report abstinence, using exhaled breath carbon monoxide (cut-off <10 parts per million [ppm]) measured with a carbon monoxide (CO) monitor

Self-report of not smoking cigarettes [not even a puff] in the 7 days before the 30-day follow-up

Self-report of not smoking cigarettes [not even a puff] in the 7 days before the 56-day follow-up

Self-report of not smoking cigarettes [not even a puff] in the 7 days before the 6-month follow-up

urge to smoke using the Mood and Physical Symptoms Scale [MPSS] at baseline and 6 months; a higher score indicates a stronger urge to smoke; To assess the effect of abstinence calculate the change from baseline (just prior to stopping smoking) to the post-abstinence follow-up point for items 1 to 7 and 10 to 12, and take the raw scores for items 8 and 9

Number of cigarettes smoked daily if still smoking

Time to first cigarette smoked after the initial quit, even a single puff

Time to return to regular smoking for three or more concurrent days after a period of abstinence.

Complete abstinence (smoking not more than 5 cigarettes) beginning on the quit date and lasting until the assessment at 6 months post-randomization with biochemical verification for those who report abstinence, using exhaled breath carbon monoxide (cut-off <10 ppm) measured with a carbon monoxide (CO) monitor.

*Cigarettes smoked within 5 days of randomization will be discounted.

Seroma- wound drainage or repeated dressings required; Wound dehiscence or delayed wound healing

Infection - defined as a pathologic process caused by the invasion of normally sterile tissue, fluid, or body cavity by pathogenic or potentially pathogenic organisms.

Surgical site infection- An infection that occurs within 30 days after surgery and involves the skin, subcutaneous tissue of the incision (superficial incisional), or the deep soft tissue (e.g., fascia, muscle) of the incision (deep incisional).

Sepsis- Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). Sepsis requires a quick Sequential Organ Failure Assessment (qSOFA) Score ≥2 points due to infection. The qSOFA includes the following items and scoring system: 1. altered mental status (1 point); 2. systolic blood pressure ≤100 mm Hg (1 point); and 3. respiratory rate ≥22 breaths per minute (1 point).

Pneumonia - defined as an acute infection of the pulmonary parenchyma that is associated with at least one sign or symptom of lower respiratory acute infection (e.g., cough, pleuritic chest pain) or acute systemic illness (e.g., fever, chills, confusion, hypoxemia); accompanied by the presence of an acute infiltrate/consolidation on a chest radiograph or auscultatory findings consistent with pneumonia (such as crackles and/or localized rales) for which there is no other explanation.

Respiratory insufficiency requiring ventilatory support - Patient intubated or put on bilevel positive airway pressure (BiPAP).

according to the 4th universal definition

The diagnosis of PE requires any one of the following:

• A high probability ventilation/perfusion lung scan,
• An intraluminal filling defect of a segmental or larger artery on a helical computerized tomography (CT) scan,
• An intraluminal filling defect on pulmonary angiography, or
• A positive diagnostic test for deep venous thrombosis A. Non-diagnostic ventilation/perfusion lung scan B. Non-diagnostic helical CT scan.

The diagnosis of proximal DVT (leg or arm) requires:

• Thrombosis involving the popliteal vein or more proximal veins for leg DVT and axillary or more proximal veins for arm DVT, AND
• Evidence of vein thrombosis by any one of the following:

• A persistent intraluminal filling defect on contrast venography, 2. Non-compressibility of one or more venous segments on B mode compression ultrasonography, or 3. A clearly defined intraluminal filling defect on contrast enhanced computed tomography.

Stroke is defined as either: 1. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting ≥24 hours or leading to death; or 2. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting <24 hours with positive neuroimaging consistent with a stroke.

Nonfatal cardiac arrest is defined as successful resuscitation from either documented or presumed ventricular fibrillation, sustained ventricular tachycardia, asystole, or pulseless electrical activity requiring cardiopulmonary resuscitation, pharmacological therapy, or cardiac defibrillation.

The definition of death is all cause mortality.

Defined as time of hospital admission to time of discharge from hospital after index surgery.

Acute-hospital care is a composite outcome of hospital re-admission (patient admission to an acute-care hospital) and emergency department visit (patient visit to an emergency department, which includes urgent-care centre visit).

Data on hospital re-admission, healthcare utilization, and costs of health service utilization will be obtained from the Institute for Clinical Evaluative Sciences data repository. Administrative databases used to describe the health service utilization include: 1. Registered Persons Database - demographics and vital statistics of all legal residents of Ontario; 2. Discharge Abstract Database - records of inpatient hospitalizations from the Canadian Institute for Health Information (CIHI); 3. Ontario Health Insurance Plan Database - physician billing claims, and the National Ambulatory Care Reporting System - information on emergency department visits from CIHI.

HRQoL will be measured with the EQ-5D-5L instrument (https://euroqol.org/eq-5d-instruments/sample-demo) due to its increased sensitivity and validation in several countries including Canada. The EQ-5D-5L is also recommended in Canada to calculate the Quality Adjusted Life Years (QALYs) when conducting cost-effectiveness analyses.