Intervention for Smoking Cessation in Pre-Surgical Patients.

Last updated: July 18, 2023
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Smoking Cessation

Treatment

Intensive intervention for smoking cessation

Brief intervention for smoking cessation

Clinical Study ID

NCT05961813
PR-483/2021
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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)

Study Design

Total Participants: 232
Treatment Group(s): 2
Primary Treatment: Intensive intervention for smoking cessation
Phase:
Study Start date:
May 20, 2023
Estimated Completion Date:
January 01, 2026

Study 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.

Connect with a study center

  • Hospital Universitari Vall d'Hebron

    Barcelona, Catalunya 08035
    Spain

    Active - Recruiting

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