Alcohol Cessation Intervention in an Acute Surgical Setting

Postoperative Complications Clinical Trial

Official title:

Scand-Ankle: A Gold Standard Programme for Alcohol Cessation Intervention in Patients Undergoing Acute Fracture Surgery - A Randomised Clinical Multi-centre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986791
• Other study ID #: Scand-Ankle
• Status: Completed
• Phase: N/A
• First received: September 29, 2009
• Last updated: March 29, 2018
• Start date: May 2010
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2018
• Est. primary completion date: January 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Fracture Surgery
• Alcohol Cessation Intervention
• Ankle Injuries
• Infection
• Postoperative Complications

Intervention

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)

Locations

Country	Name	City	State
Denmark	Hospital Of South West Denmark	Aabenraa
Denmark	Bispebjerg University Hospital	Copenhagen
Denmark	Hvidovre University Hospital	Hvidovre	Copenhagen

Sponsors (6)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Hospital of South West Denmark, Hvidovre University Hospital, Karolinska Institutet, Lund University, National Board of Health, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Tønnesen 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 (Sc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Complications	A composite outcome including postoperative infections, second surgery, dislocated fracture, mal-union and other complications requiring treatment (neurological, pneumonia, thrombosis etc.)	6 weeks + 3,6,9 and 12 months
Secondary	Alcohol Intake	Continuous Alcohol Abstinence: 6 weeks Alcohol Abstinence and low-risk drinking: 3,6,9 and 12 months	6 weeks + 3,6,9 and 12 months
Secondary	Cost-Effectiveness	Cost-Effectiveness regarding postoperative complications and alcohol intake Cost-Utility regarding quality of life	6 weeks + 3,6,9 and 12 months