Efficacy of a preoperative smoking cessation intervention in orthopedic and general and urological surgery patients: A study protocol for a randomized clinical trial.

UNLABELLED: Tobacco use is a major risk factor for any surgical intervention. Offering patients help with giving up smoking before surgery increases cessation rates and lowers the risk of complications. The aim of this clinical trial is to evaluate the efficacy of an intensive presurgical intervention for promoting smoking cessation in smokers undergoing either orthopedic surgery with implants or general/urological surgery. We will conduct a stratified randomized clinical trial [intervention group (IG) and control group (CG), 1:1 allocation] at the Vall d'Hebron University Hospital, Barcelona, Spain. The IG will receive intensive help to quit smoking (psychoeducational and behavioral support, nicotine replacement therapy with follow-up, and an information leaflet). The CG will receive brief advice and the same information leaflet in a single session. Sample size was calculated to include four equal groups (IG and CG in both types of surgery) with an estimated difference of 15 points in abstinence between IG and CG; assuming a loss to follow-up of 10%, a total of 232 subjects will be needed (58 per group). The primary dependent variables are self-reported and verified abstinence from tobacco consumption (expired CO) and surgical complications. We will conduct descriptive and bivariate statistical analysis for independent data. Logistic regression will be performed to assess the efficacy of the intervention. The relative risk of surgical complications will be calculated using Cox regression models. Patient recruitment began in May 2023. This trial will be the first to evaluate an intervention of this nature in Spain. If its efficacy is demonstrated, the results will support the design of a protocol for a smoking cessation program aimed at smokers who are scheduled for surgery.

CLINICAL TRIAL REGISTRATION: The study is registered on the official website of ClinicalTrials.gov.

IDENTIFIER: ID NCT05961813.