Facial Palsy Clinical Trial
Official title:
Assessment of Corticosteroid Effect in the Prevention of Facial Palsy After Cerebella-pontine Angle Surgery
Verified date | July 2012 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
Facial palsy after surgical removal of cranial base tumors adherent to the nerve can partly be explained by inflammation.
Status | Completed |
Enrollment | 313 |
Est. completion date | January 2011 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - adults patients - surgery of base crane tumors - accept to participate - having health insurance Exclusion Criteria: - pregnant woman - children - known allergy to steroids - preoperative facial palsy of grade >2 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | Assistance Publique Hopitaux de Paris | Clichy |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of the facial function at 8 days postoperative | at 8 days postoperative | Yes | |
Secondary | Assessment of the facial function at 1 day postoperative | at 1 day postoperative | Yes |
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