Alcohol Cessation Intervention in an Acute Surgical Setting

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00986791

Enrollment

Registered

2009-09-30

Start date

2010-05-31

Completion date

2018-03-31

Last updated

2018-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

risk reduction

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 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.

Interventions

OTHERGSP-A

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative Complications	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.)

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026