Carcinomatous Disease
Conditions
Keywords
laryngectomy, artificial larynx, breathing, swallowing, upper airway
Brief summary
This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.
Interventions
DEVICEPROTIP MEDICAL ( Artificial larynx prosthesis)
establishment of an artificial larynx prosthesis
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Anyone over 18 years, male or female, with a carcinomatous disease of the upper airways requiring a total laryngectomy
Exclusion criteria
* Less than 18 years * Contraindications to general anesthesia * Any situation considered by the physician operator as an exclusion * Pregnant women * Lactating women * Subglottic or basi-lingual tumor extension more than 1 cm * Prior radiotherapy * Severe coagulation disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the restoration of respiratory functions | one year | 4 items will be used: * 0: no dyspnea * 1: moderate dyspnea * 2: significant dyspnea * 3: major dyspnea |
| Evaluation of the restoration of the ability to swallow by nasofibroscopy | one year | 3 items will be used: * 1: no aspiration * 2: moderate aspiration * 3: massive aspiration |
Countries
France
Contacts
Primary ContactChristian DEBRY, PU-PH
Outcome results
None listed