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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group in protesic implant orthopedic surgery | Experimental | 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. |
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| Intervention group in general and urological surgery | Experimental | 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. |
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| Control group in protesic implant orthopedic surgery | Active Comparator | 58 patients programmed for knee or hip replacement surgeries, or spinal arthrodesis surgery who will receive a brief intervention for smoking cessation. |
|
| Control group in general and urological surgery | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive intervention for smoking cessation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tobacco use | Change in self reported tobacco use (smoking) | Evaluated at 1, 3, 6, and 12 months after surgical intervention |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Gavilán Castillo, RN; MSN | Contact | 934893000 | 8021 | eva.gavilan@vallhebron.cat |
| Name | Affiliation | Role |
|---|---|---|
| Eva Gavilán Castillo, RN; MSN | Vall d'Hebron Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Catalonia | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41111564 | Derived | Gavilan E, Fernandez E, Minguell J, Trilla E, Sanchez JM, Espin-Basany E, Zuriguel E, Alvarez C, Montllor I, Ferre M, Aneas S, Gayubas A, Botana C, Colmenero M, Perez G, Rodriguez N, Gili N, Martinez C. Efficacy of a preoperative smoking cessation intervention in orthopedic and general and urological surgery patients: A study protocol for a randomized clinical trial. Tob Induc Dis. 2025 Oct 17;23. doi: 10.18332/tid/203550. eCollection 2025. |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Randomized, open, controlled clinical trial.
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| Brief intervention for smoking cessation | Behavioral | 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. |
|
| 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. |
| D001523 |
| Mental Disorders |