We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alcohol Cessation Intervention in an Acute Surgical Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00986791
Recruitment Status : Unknown
Verified April 2014 by Hanne Tonnesen, Bispebjerg Hospital.
Recruitment status was:  Recruiting
First Posted : September 30, 2009
Last Update Posted : April 15, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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
Acute Fracture Surgery Alcohol Cessation Intervention Postoperative Complications Infection Ankle Injuries Other: Gold Standard Programme for Alcohol Cessation Intervention

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Study Start Date : November 2009
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Control group
Experimental: Intervention group Other: Gold Standard Programme for Alcohol Cessation Intervention
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)


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Contacts and Locations

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


Contacts
Contact: Hanne Tønnesen, Professor hanne.tonnesen@regionh.dk

Locations
Denmark
Hvidovre University Hospital Recruiting
Hvidovre, Copenhagen, Denmark, 2650
Contact: Ina Stark, Study Nurse       Ina.Hjortkjaer.Stark@regionh.dk   
Principal Investigator: Bjørn Lindegaard Madsen, MD         
Hospital Of South West Denmark Recruiting
Aabenraa, Denmark
Contact: Helle Staulund, Study Nurse       hsstaulund@privat.dk   
Principal Investigator: Christian Akim Jacobsen, MD         
Bispebjerg University Hospital Recruiting
Copenhagen, Denmark
Contact: Julie Weber, MD       jegh0006@regionh.dk   
Principal Investigator: Jes Bruun Lauritzen, Professor         
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: April 15, 2014
Last Verified: April 2014

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