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Alcohol Intervention in an Acute Surgical Setting

This study is currently recruiting participants.
Verified May 2010 by Bispebjerg Hospital
Sponsor:
Collaborators:
Hvidovre University Hospital
Helse Stavanger HF
Haukeland University Hospital
Lund University
Karolinska Institutet
National Board of Health, Denmark
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00986791
First received: September 29, 2009
Last updated: March 24, 2011
Last verified: May 2010
History of Changes
  Purpose

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 an intensive patient education programme aimed to stop drinking in the perioperative period compared to the daily routine guidelines for alcohol patients undergoing emergency surgical procedures.


Condition Intervention
Acute Surgery
Alcohol Intervention
Postoperative Morbidity
Infection
Ankle Injuries
 Other: Postoperative alcohol cessation intervention programme
Other: Standard treatment

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: Development of an Evidence-based Education Programme for Alcohol Patients With Ankle Fractures in Scandinavia - A Randomised Clinical Multi-centre Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Postoperative complications requiring treatment [ Time Frame: 6 weeks + 3,6,9 and 12 months ] [ Designated as safety issue: No ]
  • Frequency of non-alcohol patients(biochemical validated) [ Time Frame: 6 weeks + 3,6,9 and 12 months ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: 6 weeks + 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Nursing care [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Reconvalescence (time until returning to work) [ Time Frame: 6 weeks + 3,6,9 and 12 months ] [ Designated as safety issue: No ]
  • Self-evaluated health [ Time Frame: 6 weeks + 3,6,9 and 12 months ] [ Designated as safety issue: No ]
  • Degree of alcohol withdrawal symptoms [ Time Frame: 6 weeks + 3,6,9 and 12 months ] [ Designated as safety issue: No ]
  • Alcohol markers [ Time Frame: 6 weeks + 3,6,9 and 12 months ] [ Designated as safety issue: No ]
  • Estimates of cost-effectiveness regarding changes in QALY [ Time Frame: 6 weeks + 3,6,9 and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: November 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group Other: Standard treatment
All the control patients receive the routine procedure for alcohol patients during and after surgery
Experimental: Intervention group Other: Postoperative alcohol cessation intervention programme
1 month programme: Clear plan and goal consisting of weekly follow-up meetings, 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 24 hours after entering the hospital

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986791

Contacts
Contact: Hanne Tønnesen, MD, DMSc +4535313531 ext 3947 hanne.tonnesen@bbh.regionh.dk

Locations
Denmark
Hvidovre University Hospital Recruiting
Hvidovre, Copenhagen, Denmark, 2650
Contact: Bolette Pedersen, MSc         bped0046@bbh.regionh.dk    
Bispebjerg University Hospital Recruiting
Copenhagen, Denmark
Contact: Bolette Pedersen, MSc         bped0046@bbh.regionh.dk    
Principal Investigator: Bolette Pedersen, MSc            
Norway
Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Kristian Oppedal, MD         kristian.oppedal@sus.no    
Principal Investigator: Kristian Oppedal, MD            
Stavanger University Hospital Recruiting
Stavanger, Norway
Contact: Kristian Oppedal, MD         kristian.oppedal@sus.no    
Principal Investigator: Kristian Oppedal, MD            
Sweden
Malmö University Hospital Active, not recruiting
Malmö, Sweden
Sponsors and Collaborators
Bispebjerg Hospital
Hvidovre University Hospital
Helse Stavanger HF
Haukeland University Hospital
Lund University
Karolinska Institutet
National Board of Health, Denmark
Investigators
Principal Investigator: Hanne Tønnesen, MD, DMSc WHO-CC, Bispebjerg University Hospital
Principal Investigator: Sverre Nesvåg, PHD KORFOR, Stavanger University Hospital
Principal Investigator: Mats Berglund, Professor Clinical Alcohol Research, UMAS, Lund University
  More Information

No publications provided

Responsible Party: Hanne Tønnesen, WHO-CC, Bispebjerg Hospital, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00986791     History of Changes
Other Study ID Numbers: Scand-Ankle
Study First Received: September 29, 2009
Last Updated: March 24, 2011
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Bispebjerg Hospital:
risk reduction

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and 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 May 16, 2013