Alcohol Cessation Intervention in an Acute Surgical Setting

Not Applicable

Completed

• Conditions: Postoperative Complications; Alcohol Cessation Intervention; Acute Fracture Surgery; Infection; Ankle Injuries
• Interventions: Other: GSP-A

• Registration Number: NCT00986791
• Lead Sponsor: Bispebjerg Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Study Start: 2010-05
• Primary Completion: 2016-01-01
• Status Verified: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-03-29
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSP-A	GSP-A	Gold-Standard-Program for Alcohol cessation intervention (GSP-A): 6-week intensive patient education program with pharmaceutical support

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cost-Effectiveness	6 weeks + 3,6,9 and 12 months	Cost-Effectiveness regarding postoperative complications and alcohol intake Cost-Utility regarding quality of life
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

Trial Locations

Locations (3)

Bispebjerg University Hospital; 🇩🇰 Copenhagen, Denmark

Hvidovre University Hospital; 🇩🇰 Hvidovre, Copenhagen, Denmark

Hospital Of South West Denmark; 🇩🇰 Aabenraa, Denmark