Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961813
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-07-03
Brief Title:
Intervention for Smoking Cessation in Pre-Surgical Patients
Sponsor:
Hospital Universitari Vall dHebron Research Institute
Organization:
Hospital Universitari Vall dHebron Research Institute
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 questions 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None