Status:
COMPLETED
Alcohol Cessation Intervention in an Acute Surgical Setting
Lead Sponsor:
Bispebjerg Hospital
Collaborating Sponsors:
Lund University
Hvidovre University Hospital
Conditions:
Acute Fracture Surgery
Alcohol Cessation Intervention
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00986791
Start Date
May 1 2010
End Date
March 1 2018
Last Update
March 30 2018
Active Locations (3)
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1
Hvidovre University Hospital
Hvidovre, Copenhagen, Denmark, 2650
2
Hospital Of South West Denmark
Aabenraa, Denmark
3
Bispebjerg University Hospital
Copenhagen, Denmark