Abstract
BACKGROUND: 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. DISCUSSION: 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. TRIAL REGISTRATION: The protocol is registered in ClinicalTrials.gov (Id: NCT00986791 ).