Intervention for Smoking Cessation in Pre-Surgical Patients.

Smoking Cessation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961813
• Other study ID #: PR-483/2021
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: July 2023
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Eva Gavilán Castillo, RN; MSN
• Phone: 934893000
• Email: eva.gavilan[@]vallhebron.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: January 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation
• Surgical Procedure, Unspecified

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Catalunya

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tobacco use	Change in self reported tobacco use (smoking)	Evaluated at 1, 3, 6, and 12 months after surgical intervention
Secondary	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
Secondary	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
Secondary	Changes in tobacco use pattern	Amount and frequency (daily, weekly, sporadically)	Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in self-efficacy	Albert Bandura's social cognitive theory	Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
Secondary	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.
Secondary	Surgery duration	Time spent in the operation room	Day of intervention
Secondary	Need of blood transfusion	Volume of blood transfused during surgery	Day of intervention
Secondary	Hospitalization duration	Number of days of hospitalization after surgery.	Days from admitting until discharge.
Secondary	Need of new hospitalizations	Number of times patient is admitted to the hospital during follow up	12 months after surgical intervention.