NCT05961813

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Smoking
• Smoking Cessation
• Surgical Procedure, Unspecified

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.

Timeline

• Start date: 2023-05-20
• Primary completion: 2025-06-01
• Completion: 2026-01-01
• First posted: 2023-07-27
• Last updated: 2023-07-27

Locations

1 site across 1 country: Spain