An interventional study of Intensive intervention for smoking cessation and Brief intervention for smoking cessation in Smoking, Smoking Cessation and Surgical Procedure, Unspecified, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Treatment
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:
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.
Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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.
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.
Tobacco use
Change in self reported tobacco use (smoking)
Time frame: Evaluated at 1, 3, 6, and 12 months after surgical intervention
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
Time frame: 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.
Time frame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
Changes in tobacco use pattern
Amount and frequency (daily, weekly, sporadically)
Time frame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
Changes in degree of nicotine dependency
Fagerström test \[low dependency (0-3), medium dependency (4-6), y high dependency (7-10)\]
Time frame: 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)
Time frame: 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)
Time frame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
Changes in self-efficacy
Albert Bandura's social cognitive theory
Time frame: 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
Time frame: Hospitalization period and 90 days after surgical intervention.
Surgery duration
Time spent in the operation room
Time frame: Day of intervention
Need of blood transfusion
Volume of blood transfused during surgery
Time frame: Day of intervention
Hospitalization duration
Number of days of hospitalization after surgery.
Time frame: Days from admitting until discharge.
Need of new hospitalizations
Number of times patient is admitted to the hospital during follow up
Time frame: 12 months after surgical intervention.
Plan to share: No
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Hospital Universitari Vall d'Hebron Research Institute