Intervention for Smoking Cessation in Pre-Surgical Patients.

Study Overview
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Brief Summary
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The goal of this clinical trial is to assess efficacy of an intensive pre-surgical intervention to quit smoking in smoking patients who will be operated on implant orthopedic surgery or general and urological surgery. The main question[s] it aims to answer are: Evaluate the efficacy of intensive pre surgical intervention to quit smoking compared to a brief intervention Evaluate the implementation of this protocol. Participants will be randomized to 2 intervention groups (patients programmed for protesic implant orthopedic surgery in the first group, and general and urological surgery) and 2 control groups (stratified in the same manner as the intervention groups), and will be monitored through telematic check ups via phone calls.

Detailed Description
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Subject recruitment in pre surgical anesthesiology consults, data collection and randomization within 48 hours of said visit. Subjects in the intensive intervention group will be sent to a specialized Preventive Medicine consult for smoking cessation, completing 6 visits (2 before surgical intervention, 4 visits withint the following 12 months). Subjects in the control group will receive brief advice on quitting smoking through a phone call the the same day randomization is performed. Both groups will receive follow up calls at months 1, 3, 6, and 12, after surgical intervetion. All patients will have their smoking habits evaluated and the relevant data about the surgical intervention collected the day of the intervention. At month 7 adecuacy of the protocol will be evaluated to assess if any modifications are necessary. Data entry and quality control of the database will be performed periodically for the duration of the study.

Official Title
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Evaluación de la Eficacia de Una intervención Para Dejar de Fumar en Pacientes prequirúrgicos de cirugía ortopédica o de cirugía General y urológica: Ensayo clínico Aleatorizado.

Conditions
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Smoking, Smoking Cessation, Surgical Procedure, Unspecified

Intervention / Treatment
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* Behavioral: Intensive intervention for smoking cessation
* Behavioral: Brief intervention for smoking cessation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must 18 years old or older, and be able to consent. Surgery programmed for at least 4 weeks after inclusion in the study. Smokers Exclusion Criteria: Pregnancy Already under treatment for smoking cessation Inability to consent due to cognitive impairment or language barrier. Non-primary knee or hip replacement surgery Participation in any study that forbids use of nicotine substitution therapy (dermal, oral)

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, open, controlled clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group in protesic implant orthopedic surgery<br>58 patients programmed for knee or hip replacement surgeries, or spinal arthrodesis surgery who will be sent to a specialized preventive medicine consult to quit smoking. | Behavioral: Intensive intervention for smoking cessation<br>* Patients will be given a brochure and presentation on smoking cessation and will complete 6 visits (2 before surgical intervention, 4 visits within the following 12 months), as well as follow up phone calls for progressi monitorization.<br>|
| Experimental: Intervention group in general and urological surgery<br>58 patients programmed for colorrectal surgery due to colorrectal cancer, cistectomy, radical prostatectomy and partial or total nefrectomy, who will be sent to a specialized preventive medicine consult to quit smoking. | Behavioral: Intensive intervention for smoking cessation<br>* Patients will be given a brochure and presentation on smoking cessation and will complete 6 visits (2 before surgical intervention, 4 visits within the following 12 months), as well as follow up phone calls for progressi monitorization.<br>|
| Active Comparator: Control group in protesic implant orthopedic surgery<br>58 patients programmed for knee or hip replacement surgeries, or spinal arthrodesis surgery who will receive a brief intervention for smoking cessation. | Behavioral: Brief intervention for smoking cessation<br>* Patients will be given a brochure and presentation on smoking cessation 4 weeks before surgery, as well as follow up phone calls for progressi monitorization.<br>|
| Active Comparator: Control group in general and urological surgery<br>58 programmed for colorrectal surgery due to colorrectal cancer, cistectomy, radical prostatectomy and partial or total nefrectomy, who will receive a brief intervention for smoking cessation. | Behavioral: Brief intervention for smoking cessation<br>* Patients will be given a brochure and presentation on smoking cessation 4 weeks before surgery, as well as follow up phone calls for progressi monitorization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco use | Change in self reported tobacco use (smoking) | Evaluated at 1, 3, 6, and 12 months after surgical intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in concentration of exhaled CO measured with a CO-oximeter | A patient will be considered as an active tobacco user if more than 6 of carboxyhemoglobin particles per million are found through the use of a CO-oximeter | Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention | 
| Changes in rate of different type of tobbaco product users | Cigarettes, cigars, rolling tobacco, etc. | Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention | 
| Changes in tobacco use pattern | Amount and frequency (daily, weekly, sporadically) | Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention | 
| Changes in degree of nicotine dependency | Fagerström test [low dependency (0-3), medium dependency (4-6), y high dependency (7-10)] | Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention | 
| Changes in disposition to smoking cessation | Prochaska and Di Clemente's model (pre contemplation, contemplation, preparation, action, maintenance or relapse) | Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention | 
| Changes in Motivation level | Richmond's test (<3 no motivation; 4-5 doubtful motivation; 6-7 moderate motivation; 8-10 high motivation) | Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention | 
| Changes in self-efficacy | Albert Bandura's social cognitive theory | Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention | 
| Number of patients with surgical complicatoins | Complications will be classified as respiratory, cardiovascular, surgical wound and complications, mortality | Hospitalization period and 90 days after surgical intervention. | 
| Surgery duration | Time spent in the operation room | Day of intervention | 
| Need of blood transfusion | Volume of blood transfused during surgery | Day of intervention | 
| Hospitalization duration | Number of days of hospitalization after surgery. | Days from admitting until discharge. | 
| Need of new hospitalizations | Number of times patient is admitted to the hospital during follow up | 12 months after surgical intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Smoking Cessation, Tobacco Use Disorder, Surgery