Scand-Ankle: A Gold Standard Programme for Alcohol Cessation Intervention in Patients Undergoing Acute Fracture Surgery - A Randomised Clinical Multi-centre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Postoperative Complications
研究概览
简要总结
Hazardous alcohol intake is an independent risk factor for postoperative complications after major and minor operations, elective and emergency procedures for men and women.
The aim of this study is to evaluate the effect of a 6-week Gold Standard Programme for alcohol cessation intervention in the perioperative period compared to the daily routine guidelines for patients with hazardous alcohol intake undergoing ankle fracture surgery.
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
- Single (Outcomes Assessor)
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
- •Drinking 21 or more drinks(one drink containing 12 g ethanol) per week for at least 3 months
- •Traumatic ankle fracture requiring internal fixation (osteosynthesis; more than just Kirschner threads or similar minor intervention)
- •Informed consent
- •Randomisation within 36 hours after entering the orthopaedic department
排除标准
- •Major trauma involving other fractures or major lesions,
- •Preoperative severe psychiatric disorders (including medicine addiction, severe alcohol dependence [defined as experience of delirium or seizures during abstinence from alcohol], dementia) or other conditions of reduced ability for giving informed consent
- •Pathological fractures
- •Pregnancy and lactation
- •Allergy to benzodiazepines, anaesthesia, pain treatment or disulfiram
- •Uncompensated chronic diseases (including fulminate cardiac or liver insufficiency, which are contraindications for disulfiram)
- •ASA score 4-5
- •Canceled operation
- •Withdrawal of informed consent
研究组 & 干预措施
Control group
Treatment as usual
GSP-A
Gold-Standard-Program for Alcohol cessation intervention (GSP-A): 6-week intensive patient education program with pharmaceutical support
干预措施: GSP-A (Other)
结局指标
主要结局
Postoperative Complications
时间窗: 6 weeks + 3,6,9 and 12 months
A composite outcome including postoperative infections, second surgery, dislocated fracture, mal-union and other complications requiring treatment (neurological, pneumonia, thrombosis etc.)
次要结局
- Cost-Effectiveness(6 weeks + 3,6,9 and 12 months)
- Alcohol Intake(6 weeks + 3,6,9 and 12 months)
研究者
Hanne Tonnesen
Professor
Bispebjerg Hospital