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Alcohol Cessation Intervention in an Acute Surgical Setting

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ClinicalTrials.gov Identifier: NCT00986791
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : March 30, 2018
Sponsor:
Collaborators:
Lund University
Hvidovre University Hospital
Hospital of South West Denmark
National Board of Health, Denmark
Karolinska Institutet
Information provided by (Responsible Party):
Hanne Tonnesen, 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.


Condition or disease Intervention/treatment Phase
Acute Fracture Surgery Alcohol Cessation Intervention Postoperative Complications Infection Ankle Injuries Other: GSP-A Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Scand-Ankle: A Gold Standard Programme for Alcohol Cessation Intervention in Patients Undergoing Acute Fracture Surgery - A Randomised Clinical Multi-centre Study
Actual Study Start Date : May 2010
Actual Primary Completion Date : January 1, 2016
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

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 Name: Gold Standard Programme




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986791


Locations
Denmark
Hvidovre University Hospital
Hvidovre, Copenhagen, Denmark, 2650
Hospital Of South West Denmark
Aabenraa, Denmark
Bispebjerg University Hospital
Copenhagen, Denmark
Sponsors and Collaborators
Bispebjerg Hospital
Lund University
Hvidovre University Hospital
Hospital of South West Denmark
National Board of Health, Denmark
Karolinska Institutet
Investigators
Principal Investigator: Hanne Tønnesen, Professor WHO-CC, Bispebjerg University Hospital

Publications of Results:
Responsible Party: Hanne Tonnesen, Professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00986791     History of Changes
Other Study ID Numbers: Scand-Ankle
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Keywords provided by Hanne Tonnesen, Bispebjerg Hospital:
risk reduction

Additional relevant MeSH terms:
Postoperative Complications
Ankle Injuries
Pathologic Processes
Leg Injuries
Wounds and Injuries
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs