Alcohol Addiction and Otorhinolaryngology Cancer
Impact for Care for Patients With Alcohol Addiction and Treated for ORL Cancer
1 other identifier
interventional
115
1 country
1
Brief Summary
The aim of the study is to compare the hospitalisation period in ORL surgery for two groups of patients. One of them will be treated for alcohol addiction to weaning them before the surgery ORL. The other group will be treated with usual methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 20, 2009
CompletedFirst Posted
Study publicly available on registry
January 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedMarch 26, 2012
December 1, 2011
3.7 years
January 20, 2009
March 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint of the study will be to compare the duration of post surgery hospitalisation between the patients who benefit with an alcohol weaning and the patient treated with usual methods.
time between the surgery and the exit of the hospital
two weeks
Secondary Outcomes (1)
The secondary objective is to note: the presence of weaning syndrome, the diagnostic of Delirium tremens, the occurrence of post surgeries complications.
two years
Study Arms (2)
2
EXPERIMENTALpatient in hospital a week before the date of surgery for the treatment of his addiction alcohol
1
NO INTERVENTIONno treatment of his addiction alcohol during a week before the date of surgery
Interventions
Patient in hospital a week before the date of surgery for the treatment of their addiction to alcohol (alcohol weaning)
Eligibility Criteria
You may qualify if:
- Age 18-80 years, male or female
- Clinically and histologically verified ORL cancer required surgery
- Patient with alcohol addiction
- Men must consume 21 glasses of wine a week
- Women must consume 14 glasses of wine a week
- CPAM affiliation
- Able to give written informed consent to participate in the study
You may not qualify if:
- Inability to give informed consent
- Patient with regulatory authority or private patient freedom
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fédération des maladies de l'appareil digestif - Hôpital ARCHET
Nice, 06202, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Albert TRAN, PhD
Centre Hospitalier Universitaire de Nice
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Department of Clinical Research and Innovation (drc)
Study Record Dates
First Submitted
January 20, 2009
First Posted
January 21, 2009
Study Start
January 1, 2009
Primary Completion
September 1, 2012
Study Completion
January 1, 2013
Last Updated
March 26, 2012
Record last verified: 2011-12