NCT00986791

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

5.7 years

First QC Date

September 29, 2009

Last Update Submit

March 29, 2018

Conditions

Acute Fracture SurgeryAlcohol Cessation InterventionPostoperative ComplicationsInfectionAnkle Injuries

Keywords

risk reduction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Alcohol Intake

    6 weeks + 3,6,9 and 12 months

  • Cost-Effectiveness

    6 weeks + 3,6,9 and 12 months

Study Arms (2)

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

Other: GSP-A

Interventions

GSP-AOTHER

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)

Also known as: Gold Standard Programme
GSP-A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hvidovre University Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

Hospital Of South West Denmark

Aabenraa, Denmark

Location

Bispebjerg University Hospital

Copenhagen, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 25925742RESULT

MeSH Terms

Conditions

Postoperative ComplicationsInfectionsAnkle InjuriesRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLeg InjuriesWounds and InjuriesBehavior

Study Officials

  • Hanne Tønnesen, Professor

    WHO-CC, Bispebjerg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 29, 2009

First Posted

September 30, 2009

Study Start

May 1, 2010

Primary Completion

January 1, 2016

Study Completion

March 1, 2018

Last Updated

March 30, 2018

Record last verified: 2018-03

Locations

DK(3)