Use of double flange voice prosthesis for periprosthetic leakage in laryngectomised patients: A prospective case‐crossover study

Abstract

Introduction Tracheoesophageal speech is considered the gold standard for rehabilitation following total laryngectomy. One of the main problems of voice prosthesis is the periprosthesis leakage. Provox Vega XtraSeal incorporates a double flange on the pharyngeal side of the prosthesis in order to avoid these failures. The aim of the study is to compare the device lifetime between the Provox Vega and Provox Vega XtraSeal and to examine possible related factors that influence their duration. Methods Prospective case‐crossover study in 20 laryngectomised patients with Provox Vega and periprothesis leakage to whom a Provox Vega XtraSeal was placed. Survival and possible factors that affect voice prosthesis were studied using Kaplan‐Meier curves and Cox Proportional Hazards Regression with Schoenfeld residuals to test the possible assumptions. Results A total of 230 prostheses were evaluated. The most frequent reason for replacement was due to an endoprosthesis leakage (n = 146, 67%) in both models. Mean lifetime of Provox Vega was 104.474 ± 7.29 days (CI 95% 90.19‐118.76) and of Provox XtraSeal was 176.76 ± 26.46 days (CI 95% 124.9‐228.61) (P = .012). Complementary treatment with radiotherapy demonstrated a higher device survival (P = .007). Discussion Provox XtraSeal seems to be effective reducing the number of changes due to periprosthetic leakage, thus increasing the survival of voice prosthesis.

Improving heat and moisture exchanger therapy with a hydrogel base adhesive in laryngectomised patients: an open, randomised, crossover trial

“…All laryngectomised patients belonging to the hospital are under prospective follow-up in a database in which device changes and causes are collected. 12,13 The inclusion criteria were: >18 years old, at least 3 months post-total laryngectomy, at least 3 months post-radiotherapy/ chemotherapy in the case of having received this type of treatment, being treated with proton-pump inhibitors and had at least three months experience with the Provox voice prosthesis, HME and adhesives. Subjects were excluded on the basis of prior medical problems preventing HME or adhesive use, recurrent or metastatic disease, use of another phonation method instead of the voice prosthesis, functional incapacity to insert and remove an HME or adhesive independently, inability to understand or provide informed consent, impaired cognitive ability, or regular use of any type of cannula.…”

Post-Laryngectomy Voice Prosthesis Changes by Speech-Language-Pathologists: Preliminary results.

“…Total laryngectomy (TL) is one of the most common procedures in head and neck surgery. The post-TL voice rehabilitation is challenging for both patients and practitioners due to the complex nature of patient presentation and the involvement of many motivational and oncological factors [1,2]. To date, tracheoesophageal speech is considered as the gold standard for post-TL voice rehabilitation [1,2].…”

“…The post-TL voice rehabilitation is challenging for both patients and practitioners due to the complex nature of patient presentation and the involvement of many motivational and oncological factors [1,2]. To date, tracheoesophageal speech is considered as the gold standard for post-TL voice rehabilitation [1,2]. The mean duration of voice prosthesis (VP) life-time ranged from 3 to 6-month, which supports the need of adequate follow-up and VP changes 3.…”

Post-Laryngectomy Voice Prosthesis Changes by Speech-Language Pathologists: Preliminary Results

“…Total laryngectomy (TL) is a common oncological surgery in head and neck surgery. The post-TL voice rehabilitation is challenging for both patients and practitioners due to the complex nature of patient presentation and the involvement of many motivational and oncological factors [ 1 , 2 ]. To date, tracheoesophageal speech is considered the gold standard for post-TL voice rehabilitation [ 1 , 2 ].…”

“…The post-TL voice rehabilitation is challenging for both patients and practitioners due to the complex nature of patient presentation and the involvement of many motivational and oncological factors [ 1 , 2 ]. To date, tracheoesophageal speech is considered the gold standard for post-TL voice rehabilitation [ 1 , 2 ]. The mean voice prosthesis (VP) lifetime ranges from 3 to 6 months, which supports the need of adequate follow-up and VP changes 3.…”