Clinical trial NCT00986791: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Fracture Surgery
Alcohol Cessation Intervention
Postoperative Complications
Infection
Ankle Injuries
Keywords: risk reduction
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Lund University
name: Hvidovre University Hospital
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: National Board of Health, Denmark
name: Karolinska Institutet
First posted: 2009-09-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Postoperative Complications
timeFrame: 6 weeks + 3,6,9 and 12 months
Secondary outcomes:
measure: Alcohol Intake
timeFrame: 6 weeks + 3,6,9 and 12 months
measure: Cost-Effectiveness
timeFrame: 6 weeks + 3,6,9 and 12 months
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
state: Copenhagen
city: Aabenraa
country: Denmark
facility: Hospital Of South West Denmark
city: Copenhagen
country: Denmark
facility: Bispebjerg University Hospital
Study officials:
affiliation: WHO-CC, Bispebjerg University Hospital
name: Hanne Tønnesen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.