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.

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking; Smoking Cessation; Surgical Procedure, Unspecified
• Intervention / Treatment: Behavioral: Intensive intervention for smoking cessation; Behavioral: Brief intervention for smoking cessation

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.

• Study Type: Interventional
• Enrollment (Estimated): 232
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Gavilán Castillo, RN; MSN; Phone Number: 8021 934893000; Email: eva.gavilan@vallhebron.cat

Study Locations

• Spain
  • Catalunya
    • Barcelona, Catalunya, Spain, 08035
      • Recruiting
      • Hospital Universitari Vall d'Hebron
      • Contact: Eva Gavilán Castillo, RN; MSN; Phone Number: 8021 934893000; Email: eva.gavilan@vallhebron.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group in protesic implant orthopedic surgery; 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.	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.
Experimental: Intervention group in general and urological surgery; 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.	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.
Active Comparator: Control group in protesic implant orthopedic surgery; 58 patients programmed for knee or hip replacement surgeries, or spinal arthrodesis surgery who will receive a brief intervention for smoking cessation.	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.
Active Comparator: Control group in general and urological surgery; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco use	Change in self reported tobacco use (smoking)	Evaluated at 1, 3, 6, and 12 months after surgical intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Investigators: Principal Investigator: Eva Gavilán Castillo, RN; MSN, Vall d'Hebron Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Smoking; Smoking Cessation; Tobacco Use Disorder
• Other Study ID Numbers: PR-483/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No