Alcohol Cessation Intervention in an Acute Surgical Setting

March 29, 2018 updated by: Hanne Tonnesen, Bispebjerg Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aabenraa, Denmark
        • Hospital of South West Denmark
      • Copenhagen, Denmark
        • Bispebjerg University Hospital
    • Copenhagen
      • Hvidovre, Copenhagen, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Treatment as usual
Experimental: GSP-A
Gold-Standard-Program for Alcohol cessation intervention (GSP-A): 6-week intensive patient education program with pharmaceutical support
Other: GSP-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)
Other Names:
  • Gold Standard Programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.)
6 weeks + 3,6,9 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks + 3,6,9 and 12 months
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
6 weeks + 3,6,9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

Karolinska Institutet
Lund University
Hvidovre University Hospital
Hospital of South West Jutland
National Board of Health, Denmark

Investigators

  • Principal Investigator: Hanne Tønnesen, Professor, WHO-CC, Bispebjerg University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2010

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (Estimate)

September 30, 2009

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Scand-Ankle

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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