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Completed

NCT Number: NCT00986791

Alcohol Cessation Intervention in an Acute Surgical Setting

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.

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Key information

Conditions

Acute Fracture Surgery Alcohol Cessation Intervention Ankle Injuries Behavior Infection Infections Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Risk Reduction Behavior Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre University Hospital, Hvidovre, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSP-A

Other

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)

Other names: Gold Standard Programme

Primary outcomes

  1. Postoperative Complications

    Time frame: 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 outcomes

  1. Alcohol Intake

    Time frame: 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

  2. Cost-Effectiveness

    Time frame: 6 weeks + 3,6,9 and 12 months

    Cost-Effectiveness regarding postoperative complications and alcohol intake Cost-Utility regarding quality of life

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Esbjerg Hospital - University Hospital of Southern Denmark
  • Hvidovre University Hospital
  • Karolinska Institutet
  • Lund University
  • National Board of Health, Denmark

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2018
First posted
Sep 30, 2009
Registry last updated
Mar 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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