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| Name | Class |
|---|---|
| Lund University | OTHER |
| Hvidovre University Hospital | OTHER |
| Esbjerg Hospital - University Hospital of Southern Denmark | OTHER |
| National Board of Health, Denmark |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Treatment as usual | |
| GSP-A | Experimental | Gold-Standard-Program for Alcohol cessation intervention (GSP-A): 6-week intensive patient education program with pharmaceutical support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSP-A | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cost-Effectiveness | Cost-Effectiveness regarding postoperative complications and alcohol intake Cost-Utility regarding quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanne Tønnesen, Professor | WHO-CC, Bispebjerg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre University Hospital | Hvidovre | Copenhagen | 2650 | Denmark | ||
| Hospital Of South West Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25925742 | Result | 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. |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D007239 | Infections |
| D016512 | Ankle Injuries |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| OTHER_GOV |
| Karolinska Institutet | OTHER |
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|
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| 6 weeks + 3,6,9 and 12 months |
| Aabenraa |
| Denmark |
| Bispebjerg University Hospital | Copenhagen | Denmark |
| D001519 | Behavior |