Clinical trial NCT05961813: Intervention for Smoking Cessation in Pre-Surgical Patients.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking
Smoking Cessation
Surgical Procedure, Unspecified
Keywords: Smoking
Smoking Cessation
Tobacco Use Disorder
Surgery
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open, controlled clinical trial.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Tobacco use
timeFrame: Evaluated at 1, 3, 6, and 12 months after surgical intervention
Secondary outcomes:
measure: Changes in concentration of exhaled CO measured with a CO-oximeter
timeFrame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
measure: Changes in rate of different type of tobbaco product users
timeFrame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
measure: Changes in tobacco use pattern
timeFrame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
measure: Changes in degree of nicotine dependency
timeFrame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
measure: Changes in disposition to smoking cessation
timeFrame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
measure: Changes in Motivation level
timeFrame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
measure: Changes in self-efficacy
timeFrame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
measure: Number of patients with surgical complicatoins
timeFrame: Hospitalization period and 90 days after surgical intervention.
measure: Surgery duration
timeFrame: Day of intervention
measure: Need of blood transfusion
timeFrame: Day of intervention
measure: Hospitalization duration
timeFrame: Days from admitting until discharge.
measure: Need of new hospitalizations
timeFrame: 12 months after surgical intervention.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Catalunya
Study officials:
affiliation: Vall d'Hebron Hospital
name: Eva Gavilán Castillo, RN; MSN
role: PRINCIPAL_INVESTIGATOR
References: