Clinical Assessment of An External Neck Brace to Support the peristomal Fixation of an Automatic Stoma Valve (ASV) in laryngectomized patients using hands-free speech: 3D stereophotogrammetrical assessment.

The gold standard for voice restoration after total laryngectomy is still the
use of a unidirectional shunt valve creating tracheoesophageal speech .
Hands-free speech is the ultimate goal to strive for, since many patients find
digital stoma occlusion uncomfortable because this draws attention to their
handicap and occupies one hand during speech. The introduction of automatic
stoma valves (ASV) was promising at first but according to the literature only
serves approximately 30% of all laryngectomees. In daily practice this number
seems to be overestimated.
The relatively low success rate of ASVs can be partially explained because of
peristomal fixation problems. High backpressure needed for voicing and unstable
fixation cause the ASV to detach. It is generally accepted that differences in
individual tracheostoma anatomy play a large role in peristomal fixation
problems. These anatomical differences were assessed in an earlier study using
a 3D stereophotogrammetrical imaging technique. This promising method not only
turned out to be an excellent tool for the measurement of several stoma
parameters such as circumference, depth, surface size and diameters, but also
facilitates calculation of absolute mean differences between two pictures of
different conditions.
Several concepts were tried to overcome fixation problems. However, stronger
glues and the introduction of different types of adhesives still could not
prevent adhesive loosening or air-leakage and sometimes even led to progressive
skin irritation.
In order to overcome or at least diminish these attachment problems, an
external neck brace (ENB) has been developed to support peristomal adhesives.
The mechanism behind this brace is that it absorbs the high pressures created
during tracheoesophageal speech.

Peristomal fixation problems after total laryngectomy of adhesives and stoma
valves are still main reasons accounting for the relatively small amount of
patients that actually use an automatic stoma valve on a daily basis. Several
concepts could not prevent these fixation problems. In order to overcome or at
least diminish these attachment problems, an external neck brace (ENB) has been
developed to support peristomal adhesives. The mechanism behind this brace is
that it absorbs the high stomal pressures created during tracheoesophageal
speech. Clinical assessment will show the extent and amount of laryngectomized
patients that will actually benefit from supported peristomal fixation with an
external neck brace.

Prospective clinical pilot study in a University Hospital setting (UMC St
Radboud).

not applicable