Tønnesen Hanne, Egholm Julie Weber, Oppedal Kristian, Lauritzen Jes Bruun, Madsen Bjørn Lindegård, Pedersen Bolette
WHO-CC, Clinical Health Promotion Centre, Bispebjerg/Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.
Clinical Health Promotion Centre, Department of Health Sciences, Lund University, Skåne University Hospital, Malmö, Sweden.
BMC Surg. 2015 May 1;15:52. doi: 10.1186/s12893-015-0035-z.
Patients with hazardous alcohol intake are overrepresented in emergency departments and surgical wards. These patients have an increased risk of postoperative complications with prolonged hospital stays and admissions to intensive care unit after surgery. In elective surgery, preoperative alcohol cessation interventions can reduce postoperative complications, but no studies have investigated the effect of alcohol cessation intervention at the time of acute fracture surgery. This protocol describes a randomised clinical trial that aims to evaluate the effect of a new gold standard programme for alcohol cessation intervention in the perioperative period regarding postoperative complications, alcohol intake and cost-effectiveness.
METHODS/DESIGN: Patients with hazardous alcohol intake undergoing ankle fracture surgery will be recruited into the trial from multiple orthopaedic wards at university hospitals in Denmark, Sweden and Norway. Included patients will be randomly allocated to either standard care or the gold standard programme aimed at complete alcohol abstinence before, during and 6 weeks after surgery. It includes a structured patient education programme and weekly interventions meetings at the orthopaedic outpatient clinic. Furthermore, patients are provided with thiamine and B-vitamins, alcohol withdrawal prophylaxis and treatment, and disulfiram to support abstinence. Alcohol intake is biochemically validated (blood, urine and breath tests) at the weekly intervention meetings and follow-up visits. Follow-up assessments will be conducted 6 weeks and 3, 6, 9 and 12 months after surgery for all patients. The effect of the gold standard programme will be assessed comparing the outcome measures between the intervention and control group at each follow-up point.
The study will provide new knowledge about how to prevent alcohol-related postoperative complications at the time of acute fracture surgery. If effective, the results will be a benefit for the clinical course, patients and society alike.
The protocol is registered in ClinicalTrials.gov (Id: NCT00986791 ).
急诊科和外科病房中，酒精摄入量有害的患者占比过高。这些患者术后并发症风险增加，住院时间延长，术后还可能需要入住重症监护病房。在择期手术中，术前戒酒干预可减少术后并发症，但尚无研究调查急性骨折手术时戒酒干预的效果。本方案描述了一项随机临床试验，旨在评估一种新的戒酒干预金标准方案在围手术期对术后并发症、酒精摄入量和成本效益的影响。
方法/设计：将从丹麦、瑞典和挪威大学医院的多个骨科病房招募酒精摄入量有害且接受踝关节骨折手术的患者参加试验。纳入的患者将被随机分配到标准护理组或金标准方案组，后者旨在让患者在手术前、手术期间及术后6周完全戒酒。该方案包括结构化的患者教育计划以及在骨科门诊每周举行的干预会议。此外，为患者提供硫胺素和B族维生素、酒精戒断预防和治疗以及双硫仑以支持戒酒。在每周的干预会议和随访中，通过生化方法验证酒精摄入量（血液、尿液和呼气测试）。对所有患者在术后6周以及术后3、6、9和12个月进行随访评估。将在每个随访点比较干预组和对照组的结果指标，以评估金标准方案的效果。
该研究将提供有关如何在急性骨折手术时预防酒精相关术后并发症的新知识。如果有效，结果将对临床病程、患者和社会都有益。
该方案已在ClinicalTrials.gov注册（编号：NCT00986791）。
