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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Tobacco use
研究概览
简要总结
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.
详细描述
- Subject recruitment in pre surgical anesthesiology consults, data collection and randomization within 48 hours of said visit.
- 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.
- At month 7 adecuacy of the protocol will be evaluated to assess if any modifications are necessary.
- Data entry and quality control of the database will be performed periodically for the duration of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must 18 years old or older, and be able to consent.
- •Surgery programmed for at least 4 weeks after inclusion in the study.
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Intensive intervention for smoking cessation (Behavioral)
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.
干预措施: Intensive intervention for smoking cessation (Behavioral)
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.
干预措施: Brief intervention for smoking cessation (Behavioral)
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.
干预措施: Brief intervention for smoking cessation (Behavioral)
结局指标
主要结局
Tobacco use
时间窗: Evaluated at 1, 3, 6, and 12 months after surgical intervention
Change in self reported tobacco use (smoking)
次要结局
- Need of new hospitalizations(12 months after surgical intervention.)
- Changes in rate of different type of tobbaco product users(Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention)
- Changes in disposition to smoking cessation(Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention)
- Surgery duration(Day of intervention)
- Changes in concentration of exhaled CO measured with a CO-oximeter(Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention)
- Changes in tobacco use pattern(Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention)
- Changes in Motivation level(Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention)
- Number of patients with surgical complicatoins(Hospitalization period and 90 days after surgical intervention.)
- Need of blood transfusion(Day of intervention)
- Hospitalization duration(Days from admitting until discharge.)
- Changes in degree of nicotine dependency(Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention)
- Changes in self-efficacy(Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention)