Laryngectomy, Prosthesis Failure, Voice
Conditions
Keywords
voice prosthesis, laryngectomy, complications
Brief summary
The tracheoesophageal voice with voice prosthesis is currently the mainstay of voice rehabilitation post laryngectomy. The primary surgical technique of tracheoesophageal fistula formation with insertion of prosthesis and quick and easy process of voice rehabilitation are main encouraging factors. However, the usage of the prosthesis relates to a significant number of complications rated from 10 to 60%. The most common reported complication is transprosthetic leakage that determines the need of device exchange. However in some patients occur more serious complications eg. periprosthetic leakage, granulation or atrophy of mucosa around the fistula, dislocation of prosthesis, that may require anti-inflammatory treatment, temporary nasogastric tube feeding or surgical procedure. The standard protocol is voice prosthesis exchange due to transprosthetic leakage. Optionally the device could be replaced regularly to prevent both transprosthetic leakage and other complication occurrence. In the study we plan to compare the benefits from regular (each three month) versus leakage-related exchange of voice prosthesis post laryngectomy including the rate of complications, fistula colonization by Candida species and patients feedback.
Interventions
DEVICEProvox prosthesis exchange
Each patient post laryngectomy will be randomly assigned to one arm of intervention. The voice prosthesis exchange in all patients will be performed in local anaesthesia. The microbiological samples with cotton swabs will be collected from tracheoesophageal fistula on prosthesis exchange. The clinical evaluation and patients satisfaction from prosthesis usage will be performed on each exchange.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients post laryngectomy with primary insertion of voice prosthesis
Exclusion criteria
* patients post laryngopharyngectomy with digestive tract reconstruction with jejunum of free flap
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of complications rate. | Control will be continued for 12 months post laryngectomy. | In both arms of the study we will compare the incidence of following complications: periprosthetic leakage, granulation or atrophy of mucosa around the fistula, dislocation of prosthesis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fistula colonization with Candida species. | Control will be continued for 12 months post laryngectomy. | We will compare microbiological results on subsequent prosthesis exchanges in both arms. |
| Prosthesis replacement scheme and patient satisfaction. | Control will be continued for 12 months post laryngectomy. | On each voice prosthesis exchange patients will be asked three questions, assessed with Visual Analog Scale, on their feedback on voice prosthesis use, procedure of prosthesis replacement and voice quality. |
Countries
Poland
Contacts
Primary ContactAnna Rzepakowska, PhD
Backup ContactDaniel Majszyk, PhD
Outcome results
None listed