AzTrials
AzTrials

SmokingNCT05961813

Intervention for Smoking Cessation in Pre-Surgical Patients.

A study testing Intensive intervention for smoking cessation and Brief intervention for smoking cessation in people with Smoking and Smoking Cessation, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intensive intervention for smoking cessation and Brief intervention for smoking cessation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
232 participants
Where
1 siteSpain
Study dates
20 May 2023to 1 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Eva Gavilán Castillo, RN; MSN contact

934893000 ext. 8021

eva.gavilan@vallhebron.cat

Spain1 site, 1 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Catalonia, 08035

    Eva Gavilán Castillo, RN; MSN, 934893000 ext. 8021, eva.gavilan@vallhebron.cat

    Recruiting

Other trials in Spain

About this study

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.

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.

Read the 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.
Being tested
Intensive intervention for smoking cessation, Brief intervention for smoking cessation
Keywords
Smoking, Smoking Cessation, Tobacco Use Disorder, Surgery
Medical subject headings
Smoking, Smoking Cessation, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive intervention for smoking cessationBehavioural

    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 cessationBehavioural

    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.

Study groups in NCT05961813
Study groupRoleWhat they receive
Intervention group in protesic implant orthopedic surgeryExperimental58 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.
Receives: Behavioral: Intensive intervention for smoking cessation
Intervention group in general and urological surgeryExperimental58 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.
Receives: Behavioral: Intensive intervention for smoking cessation
Control group in protesic implant orthopedic surgeryActive comparator58 patients programmed for knee or hip replacement surgeries, or spinal arthrodesis surgery who will receive a brief intervention for smoking cessation.
Receives: Behavioral: Brief intervention for smoking cessation
Control group in general and urological surgeryActive comparator58 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.
Receives: Behavioral: Brief intervention for smoking cessation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tobacco use

    Change in self reported tobacco use (smoking)

    Measured: Evaluated at 1, 3, 6, and 12 months after surgical intervention

Secondary outcomes (12)

  1. 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

    Measured: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention

  2. Changes in rate of different type of tobbaco product users

    Cigarettes, cigars, rolling tobacco, etc.

    Measured: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention

  3. Changes in tobacco use pattern

    Amount and frequency (daily, weekly, sporadically)

    Measured: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention

  4. Changes in degree of nicotine dependency

    Fagerström test [low dependency (0-3), medium dependency (4-6), y high dependency (7-10)]

    Measured: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention

  5. Changes in disposition to smoking cessation

    Prochaska and Di Clemente's model (pre contemplation, contemplation, preparation, action, maintenance or relapse)

    Measured: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention

  6. Changes in Motivation level

    Richmond's test (<3 no motivation; 4-5 doubtful motivation; 6-7 moderate motivation; 8-10 high motivation)

    Measured: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention

  7. Changes in self-efficacy

    Albert Bandura's social cognitive theory

    Measured: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention

  8. Number of patients with surgical complicatoins

    Complications will be classified as respiratory, cardiovascular, surgical wound and complications, mortality

    Measured: Hospitalization period and 90 days after surgical intervention.

  9. Surgery duration

    Time spent in the operation room

    Measured: Day of intervention

  10. Need of blood transfusion

    Volume of blood transfused during surgery

    Measured: Day of intervention

  11. Hospitalization duration

    Number of days of hospitalization after surgery.

    Measured: Days from admitting until discharge.

  12. Need of new hospitalizations

    Number of times patient is admitted to the hospital during follow up

    Measured: 12 months after surgical intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start20 May 2023
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, open, controlled clinical trial.
Masking
None (open label)
Enrolment
232 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05961813
Sponsor's protocol ID
PR-483/2021
Status last verified
Jul 2023
First submitted
3 Jul 2023
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gavilan E, Fernandez E, Minguell J, Trilla E, Sanchez JM, Espin-Basany E, Zuriguel E, Alvarez C, Montllor I, Ferre M, Aneas S, Gayubas A, Botana C, Colmenero M, Perez G, Rodriguez N, Gili N, Martinez C. Efficacy of a preoperative smoking cessation intervention in orthopedic and general and urological surgery patients: A study protocol for a randomized clinical trial. Tob Induc Dis. 2025 Oct 17;23. doi: 10.18332/tid/203550. eCollection 2025.

    PubMed 41111564

Questions about this trial

What is this clinical trial studying?

A study testing Intensive intervention for smoking cessation and Brief intervention for smoking cessation in people with Smoking and Smoking Cessation, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eva Gavilán Castillo, RN; MSN (934893000 ext. 8021, eva.gavilan@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tobacco use (time frame: Evaluated at 1, 3, 6, and 12 months after surgical intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05961813, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in