Alcohol Cessation Intervention in an Acute Surgical Setting

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Bispebjerg Hospital
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
ClinicalTrials.gov Identifier:
NCT00986791
First received: September 29, 2009
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Postoperative Complications [ Time Frame: 6 weeks + 3,6,9 and 12 months ] [ Designated as safety issue: No ]
    A composite outcome including postoperative infections, second surgery, dislocated fracture, mal-union and other complications requiring treatment (neurological, pneumonia, thrombosis etc.)


Secondary Outcome Measures:
  • Alcohol Intake [ Time Frame: 6 weeks + 3,6,9 and 12 months ] [ Designated as safety issue: No ]
    Continuous Alcohol Abstinence: 6 weeks Alcohol Abstinence and low-risk drinking: 3,6,9 and 12 months

  • Cost-Effectiveness [ Time Frame: 6 weeks + 3,6,9 and 12 months ] [ Designated as safety issue: No ]
    Cost-Effectiveness regarding postoperative complications and alcohol intake Cost-Utility regarding quality of life


Estimated Enrollment: 120
Study Start Date: November 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hanne Tonnesen, Professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00986791     History of Changes
Other Study ID Numbers: Scand-Ankle
Study First Received: September 29, 2009
Last Updated: April 14, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Bispebjerg Hospital:
risk reduction

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

ClinicalTrials.gov processed this record on July 10, 2014