Alcohol Cessation Intervention in an Acute Surgical Setting
Information source: Bispebjerg Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Fracture Surgery; Alcohol Cessation Intervention; Postoperative Complications; Infection; Ankle Injuries
Intervention: Gold Standard Programme for Alcohol Cessation Intervention (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Bispebjerg Hospital Official(s) and/or principal investigator(s): Hanne Tønnesen, Professor, Principal Investigator, Affiliation: WHO-CC, Bispebjerg University Hospital
Overall contact: Hanne Tønnesen, Professor, Email: hanne.tonnesen@regionh.dk
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Postoperative Complications
Secondary outcome: Alcohol IntakeCost-Effectiveness
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Hanne Tønnesen, Professor, Email: hanne.tonnesen@regionh.dk
Hospital Of South West Denmark, Aabenraa, Denmark; Recruiting Helle Staulund, Study Nurse, Email: hsstaulund@privat.dk Christian Akim Jacobsen, MD, Principal Investigator
Bispebjerg University Hospital, Copenhagen, Denmark; Recruiting Julie Weber, MD, Email: jegh0006@regionh.dk Jes Bruun Lauritzen, Professor, Principal Investigator
Hvidovre University Hospital, Hvidovre, Copenhagen 2650, Denmark; Recruiting Ina Stark, Study Nurse, Email: Ina.Hjortkjaer.Stark@regionh.dk Bjørn Lindegaard Madsen, MD, Principal Investigator
Additional Information
Starting date: November 2009
Last updated: April 14, 2014
|