Prosthesis Failure Clinical Trial
Official title:
Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy Considering Complications Rate, Fistula Colonization by Candida Species and Patients Satisfaction Feedback.
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.
n/a
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