Alcohol Cessation Intervention in an Acute Surgical Setting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2018-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Acute Fracture Surgery Alcohol Cessation Intervention Postoperative Complications Infection Ankle Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

GSP-A

Gold-Standard-Program for Alcohol cessation intervention (GSP-A): 6-week intensive patient education program with pharmaceutical support

Group Type EXPERIMENTAL

GSP-A

Intervention Type 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)

Interventions

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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)

Intervention Type OTHER

Other Intervention Names

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Gold Standard Programme

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No