Impact for Care for Patients With Alcohol Addiction and Treated for ORL Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- The primary endpoint of the study will be to compare the duration of post surgery hospitalisation between the patients who benefit with an alcohol weaning and the patient treated with usual methods.
研究概览
简要总结
The aim of the study is to compare the hospitalisation period in ORL surgery for two groups of patients. One of them will be treated for alcohol addiction to weaning them before the surgery ORL. The other group will be treated with usual methods.
详细描述
Alcohol, associated or not associated with tobacco, is known to increase the incidence of ORL cancer. So, in fact many patients perform their ORL surgery operation in spite of their alcohol addiction.
Many studies showed that a post surgery weaning syndrome increases morbidity and mortality.
So our study will focuses on the benefits of pre surgery medical weaning program.
The protocol is an open randomised, prospective study. The patient will be divided in two groups. In one hand, the first group is designed as "treated" will get alcohol weaning in the hospital alcohol department. The patient will be hospitalized during one week before the ORL surgery.
During this hospitalisation, the patient will receive medicinal treatment, medical follow-up and psychological counselling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, male or female
- •Clinically and histologically verified ORL cancer required surgery
- •Patient with alcohol addiction
- •Men must consume 21 glasses of wine a week
- •Women must consume 14 glasses of wine a week
- •CPAM affiliation
- •Able to give written informed consent to participate in the study
排除标准
- •Inability to give informed consent
- •Patient with regulatory authority or private patient freedom
结局指标
主要结局
The primary endpoint of the study will be to compare the duration of post surgery hospitalisation between the patients who benefit with an alcohol weaning and the patient treated with usual methods.
时间窗: two weeks
time between the surgery and the exit of the hospital
次要结局
- The secondary objective is to note: the presence of weaning syndrome, the diagnostic of Delirium tremens, the occurrence of post surgeries complications.(two years)
研究者
Department of Clinical Research and Innovation
Department of Clinical Research and Innovation (drc)
Centre Hospitalier Universitaire de Nice