Intervention for Smoking Cessation in Pre-Surgical Patients.
- Conditions
- SmokingSmoking CessationSurgical Procedure, Unspecified
- Interventions
- Behavioral: Brief intervention for smoking cessationBehavioral: Intensive intervention for smoking cessation
- Registration Number
- NCT05961813
- Brief Summary
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
1. Subject recruitment in pre surgical anesthesiology consults, data collection and randomization within 48 hours of said visit.
2. 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.
3. At month 7 adecuacy of the protocol will be evaluated to assess if any modifications are necessary.
4. Data entry and quality control of the database will be performed periodically for the duration of the study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 232
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group in protesic implant orthopedic surgery Brief intervention for smoking cessation 58 patients programmed for knee or hip replacement surgeries, or spinal arthrodesis surgery who will receive a brief intervention for smoking cessation. Intervention group in general and urological surgery Intensive intervention for smoking cessation 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. Intervention group in protesic implant orthopedic surgery Intensive intervention for smoking cessation 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. Control group in general and urological surgery Brief intervention for smoking cessation 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.
- Primary Outcome Measures
Name Time Method Tobacco use Evaluated at 1, 3, 6, and 12 months after surgical intervention Change in self reported tobacco use (smoking)
- Secondary Outcome Measures
Name Time Method Changes in rate of different type of tobbaco product users Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention Cigarettes, cigars, rolling tobacco, etc.
Changes in disposition to smoking cessation Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention Prochaska and Di Clemente's model (pre contemplation, contemplation, preparation, action, maintenance or relapse)
Surgery duration Day of intervention Time spent in the operation room
Changes in concentration of exhaled CO measured with a CO-oximeter Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention 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
Changes in tobacco use pattern Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention Amount and frequency (daily, weekly, sporadically)
Changes in Motivation level Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention Richmond's test (\<3 no motivation; 4-5 doubtful motivation; 6-7 moderate motivation; 8-10 high motivation)
Number of patients with surgical complicatoins Hospitalization period and 90 days after surgical intervention. Complications will be classified as respiratory, cardiovascular, surgical wound and complications, mortality
Need of blood transfusion Day of intervention Volume of blood transfused during surgery
Hospitalization duration Days from admitting until discharge. Number of days of hospitalization after surgery.
Changes in degree of nicotine dependency Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention Fagerström test \[low dependency (0-3), medium dependency (4-6), y high dependency (7-10)\]
Changes in self-efficacy Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention Albert Bandura's social cognitive theory
Need of new hospitalizations 12 months after surgical intervention. Number of times patient is admitted to the hospital during follow up
Trial Locations
- Locations (1)
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Catalunya, Spain