Back to resultsAlcohol Cessation Intervention in an Acute Surgical Setting
Primary Purpose
Acute Fracture Surgery, Alcohol Cessation Intervention, Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
GSP-A
Sponsored by
About this trial
This is an interventional prevention trial for Acute Fracture Surgery focused on measuring risk reduction
Eligibility 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
Sites / Locations
- Hvidovre University Hospital
- Hospital Of South West Denmark
- Bispebjerg University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
GSP-A
Arm Description
Treatment as usual
Gold-Standard-Program for Alcohol cessation intervention (GSP-A): 6-week intensive patient education program with pharmaceutical support
Outcomes
Primary Outcome Measures
Postoperative Complications
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
Continuous Alcohol Abstinence: 6 weeks Alcohol Abstinence and low-risk drinking: 3,6,9 and 12 months
Cost-Effectiveness
Cost-Effectiveness regarding postoperative complications and alcohol intake Cost-Utility regarding quality of life
Full Information
NCT ID
NCT00986791
First Posted
September 29, 2009
Last Updated
March 29, 2018
Sponsor
Bispebjerg Hospital
Collaborators
Lund University, Hvidovre University Hospital, Hospital of South West Jutland, National Board of Health, Denmark, Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT00986791
Brief Title
Alcohol Cessation Intervention in an Acute Surgical Setting
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 Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2010 (Actual)
Primary Completion Date
January 1, 2016 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
Lund University, Hvidovre University Hospital, Hospital of South West Jutland, National Board of Health, Denmark, Karolinska Institutet
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Fracture Surgery, Alcohol Cessation Intervention, Postoperative Complications, Infection, Ankle Injuries
Keywords
risk reduction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Treatment as usual
Arm Title
GSP-A
Arm Type
Experimental
Arm Description
Gold-Standard-Program for Alcohol cessation intervention (GSP-A): 6-week intensive patient education program with pharmaceutical support
Intervention Type
Other
Intervention Name(s)
GSP-A
Other Intervention Name(s)
Gold Standard Programme
Intervention Description
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)
Primary Outcome Measure Information:
Title
Postoperative Complications
Description
A composite outcome including postoperative infections, second surgery, dislocated fracture, mal-union and other complications requiring treatment (neurological, pneumonia, thrombosis etc.)
Time Frame
6 weeks + 3,6,9 and 12 months
Secondary Outcome Measure Information:
Title
Alcohol Intake
Description
Continuous Alcohol Abstinence: 6 weeks Alcohol Abstinence and low-risk drinking: 3,6,9 and 12 months
Time Frame
6 weeks + 3,6,9 and 12 months
Title
Cost-Effectiveness
Description
Cost-Effectiveness regarding postoperative complications and alcohol intake Cost-Utility regarding quality of life
Time Frame
6 weeks + 3,6,9 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanne Tønnesen, Professor
Organizational Affiliation
WHO-CC, Bispebjerg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
State/Province
Copenhagen
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Hospital Of South West Denmark
City
Aabenraa
Country
Denmark
Facility Name
Bispebjerg University Hospital
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
25925742
Citation
Tonnesen H, Egholm JW, Oppedal K, Lauritzen JB, Madsen BL, Pedersen B. Patient education for alcohol cessation intervention at the time of acute fracture surgery: study protocol for a randomised clinical multi-centre trial on a gold standard programme (Scand-Ankle). BMC Surg. 2015 May 1;15:52. doi: 10.1186/s12893-015-0035-z.
Results Reference
result
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Alcohol Cessation Intervention in an Acute Surgical Setting
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