Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Laryngectomy, Voice, Prosthesis Failure

Intervention / Treatment
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* Device: Provox prosthesis exchange


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regular exchange<br>Patients will be appointed each 3 months for regular exchange of voice prosthesis. | Device: Provox prosthesis exchange<br>* 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.<br>|
| Active Comparator: Leakage exchange<br>Patients will have voice prosthesis exchange when leakage occurs. | Device: Provox prosthesis exchange<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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voice prosthesis, laryngectomy, complications