Intervention for Smoking Cessation in Pre-Surgical Patients.
NCT ID: NCT05961813
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
232 participants
INTERVENTIONAL
2023-05-20
2026-01-01
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group in protesic implant orthopedic surgery
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.
Intensive 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.
Intervention group in general and urological surgery
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.
Intensive 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.
Control group in protesic implant orthopedic surgery
58 patients programmed for knee or hip replacement surgeries, or spinal arthrodesis surgery who will receive a brief intervention for smoking cessation.
Brief intervention for smoking cessation
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.
Control group in general and urological surgery
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.
Brief intervention for smoking cessation
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.
Interventions
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Intensive 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.
Brief intervention for smoking cessation
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.
Eligibility Criteria
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Inclusion Criteria
* Surgery programmed for at least 4 weeks after inclusion in the study.
* Smokers
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Eva Gavilán Castillo, RN; MSN
Role: PRINCIPAL_INVESTIGATOR
Vall d'Hebron Hospital
Locations
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Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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PR-483/2021
Identifier Type: -
Identifier Source: org_study_id
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