Alcohol Cessation Intervention in an Acute Surgical Setting

Study Overview
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Brief Summary
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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.

Official Title
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Scand-Ankle: A Gold Standard Programme for Alcohol Cessation Intervention in Patients Undergoing Acute Fracture Surgery - A Randomised Clinical Multi-centre Study

Conditions
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Acute Fracture Surgery, Alcohol Cessation Intervention, Postoperative Complications, Infection, Ankle Injuries

Intervention / Treatment
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* Other: GSP-A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Treatment as usual | |
| Experimental: GSP-A<br>Gold-Standard-Program for Alcohol cessation intervention (GSP-A): 6-week intensive patient education program with pharmaceutical support | Other: GSP-A<br>* 6-week Gold Standard Programme (5 meetings in total) consisting a structured education programme, hotline, thiamine and B-vitamins (300 mg daily), Alcohol Withdrawal Prophylaxis and intervention (Benzodiazepines)and controlled Disulfiram support (200 mg x 2 weekly)<br>* Other names: Gold Standard Programme;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Complications | A composite outcome including postoperative infections, second surgery, dislocated fracture, mal-union and other complications requiring treatment (neurological, pneumonia, thrombosis etc.) | 6 weeks + 3,6,9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Intake | Continuous Alcohol Abstinence: 6 weeks Alcohol Abstinence and low-risk drinking: 3,6,9 and 12 months | 6 weeks + 3,6,9 and 12 months | 
| Cost-Effectiveness | Cost-Effectiveness regarding postoperative complications and alcohol intake Cost-Utility regarding quality of life | 6 weeks + 3,6,9 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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risk reduction