Prosthesis Failure Clinical Trial
— RvLPEOfficial 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.
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 10, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Otorhinolaryngology, Head andNeck Surgery of Medical University of Warsaw | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of complications rate. | 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 | Control will be continued for 12 months post laryngectomy. | |
Secondary | Fistula colonization with Candida species. | We will compare microbiological results on subsequent prosthesis exchanges in both arms. | Control will be continued for 12 months post laryngectomy. | |
Secondary | Prosthesis replacement scheme and patient satisfaction. | 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. | Control will be continued for 12 months post laryngectomy. |
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