Intervention for Smoking Cessation in Pre-Surgical Patients.
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.
1 other identifier
interventional
232
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2023
CompletedFirst Submitted
Initial submission to the registry
July 3, 2023
CompletedFirst Posted
Study publicly available on registry
July 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedJuly 27, 2023
July 1, 2023
2 years
July 3, 2023
July 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tobacco use
Change in self reported tobacco use (smoking)
Evaluated at 1, 3, 6, and 12 months after surgical intervention
Secondary Outcomes (12)
Changes in concentration of exhaled CO measured with 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
Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
Changes in tobacco use pattern
Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
Changes in degree of nicotine dependency
Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
Changes in disposition to smoking cessation
Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
- +7 more secondary outcomes
Study Arms (4)
Intervention group in protesic implant orthopedic surgery
EXPERIMENTAL58 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.
Intervention group in general and urological surgery
EXPERIMENTAL58 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.
Control group in protesic implant orthopedic surgery
ACTIVE COMPARATOR58 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 COMPARATOR58 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients must 18 years old or older, and be able to consent.
- Smokers
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, 08035, Spain
Related Publications (1)
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.
PMID: 41111564DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Gavilán Castillo, RN; MSN
Vall d'Hebron Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2023
First Posted
July 27, 2023
Study Start
May 20, 2023
Primary Completion
June 1, 2025
Study Completion
January 1, 2026
Last Updated
July 27, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share