Intervention for Smoking Cessation in Pre-Surgical Patients.

NCT ID: NCT05961813

Last Updated: 2023-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-20

Study Completion Date

2026-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Smoking Cessation Surgical Procedure, Unspecified

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, open, controlled clinical trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Intensive intervention for smoking cessation

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Intensive intervention for smoking cessation

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Brief intervention for smoking cessation

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Brief intervention for smoking cessation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eva Gavilán Castillo, RN; MSN

Role: PRINCIPAL_INVESTIGATOR

Vall d'Hebron Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Eva Gavilán Castillo, RN; MSN

Role: CONTACT

934893000 ext. 8021

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Eva Gavilán Castillo, RN; MSN

Role: primary

934893000 ext. 8021

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 41111564 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PR-483/2021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PeRiopEratiVE SmokiNg CessaTion Trial
NCT05102123 ACTIVE_NOT_RECRUITING PHASE3
Smoking Cessation Study
NCT05602753 UNKNOWN
Quitline Use in Surgical Patients
NCT00656500 COMPLETED NA