Intervention for Smoking Cessation in Pre-Surgical Patients.

Vall d'Hebron University Hospital (HUVH)

Status: Enrolling

Conditions: Surgical Procedure, Unspecified; Smoking; Smoking Cessation

Treatments: Behavioral: Intensive intervention for smoking cessation; Behavioral: Brief intervention for smoking cessation

Study type: Interventional

Funder types: Other

Identifiers

NCT05961813

PR-483/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 232 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

232 participants in 4 patient groups

Intervention group in protesic implant orthopedic surgery

Experimental group

Description:

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.

Treatment:

Behavioral: Intensive intervention for smoking cessation

Intervention group in general and urological surgery

Experimental group

Description:

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.

Treatment:

Behavioral: Intensive intervention for smoking cessation

Control group in protesic implant orthopedic surgery

Active Comparator group

Description:

58 patients programmed for knee or hip replacement surgeries, or spinal arthrodesis surgery who will receive a brief intervention for smoking cessation.

Treatment:

Behavioral: Brief intervention for smoking cessation

Control group in general and urological surgery

Active Comparator group

Description:

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.

Treatment:

Behavioral: Brief intervention for smoking cessation