Taste Disturbance Clinical Trial
Official title:
Taste Disorders in Middle Ear Disease and After Middle Ear Surgery
Objectives
To evaluate the impact of taste disturbance in different types of chronic middle ear
diseases and after middle ear surgery.
Hypothesis
That patients with chronic otitis media and cholesteatoma has taste disturbance already
before surgery due to the disease itself, of course depending on degree of the disease.
That patients with otosclerosis, has a normal nerve function before surgery.
That patients with normal taste before surgery are more likely to notices a taste
disturbance.
That nerve in continuity after surgery, even if it is maltreated, gives less taste
disturbance than a divided nerve.
Methods
A clinical study has been launched that measures taste function with two different methods
for taste measurements, electrogustometry (EGM) and the filter paper disc method (FPD)
before and after middle ear surgery in patients operated with middle ear surgery because of
otosclerosis, chronic otitis media and cholesteatoma. The investigators plan to include 120
patients in this study.
A parallel study of the patients own experience of the symptom has also been launched were
the patients answer a questionary and a quality of life document. The investigators plan to
include 300 patients in this study.
A histological study where specimens of CTN from healthy ears and from ears with chronic
disease will be investigated with electron microscopy has also started.
Taste sensations are provided by three different nerves of which the chorda tympani nerve
(CTN) is the major taste nerve. It innervates taste buds in the two anterior thirds of the
tongue. The CTN location in the middle ear predisposes for trauma of the nerve. In various
forms of middle ear pathology, such as chronic otitis and cholesteatoma the nerve can be
affected by the pathologic process per se, since the nerve may become exposed to bacteria
toxins, enzymes or mechanical damage. During middle ear surgery, it can be cut off,
stretched, touched or dried out by the heat of the microscope light beam. The nerve function
in these situations is not clarified. Is it for example better to cut the nerve than to
leave it traumatized after surgery. Therefore previous reports on objective CTN function
pre- and postoperatively unfortunate suffer from inadequate descriptions of ear disease that
were studied. In order to elucidate these questions and to give the surgeon deeper knowledge
about how to handle CTN during surgery a prospective study is initiated on patients to be
operated on with primary middle ear surgery.
We believe that patients with chronic otitis media and cholesteatoma has taste disturbance
already before surgery due to the disease itself, of course depending on degree of the
disease, and that patients with otosclerosis has a normal nerve function before surgery. We
also believe that patients with normal taste before surgery are more likely to notice a
taste disturbance and that a nerve in continuity after surgery, even if it is maltreated,
gives less taste disturbance than a divided nerve. Two methods of taste measuring are used
in the study, Electrogustometry (EGM) and a Filter Paper Disc method (FPD). We have
evaluated EGM regarding possible bias and artifacts as well as the correlation regarding
results from the two methods.
The study contains three substudies or arms.
1. A clinical prospective trial where 100 patients that undergoes primary middle ear
surgery because of chronic otitis, cholesteatoma or otosclerosis are evaluated with EGM
and FPD before and after surgery. They also answer a questionnaire about subjective
taste disturbance and a questionnaire about quality of life.
2. A clinical multi center study on 200 patients that undergoes primary surgery because of
otosclerosis. These patients answer a questionnaire about subjective taste disturbance
and a questionnaire about quality of life.
3. A histological study with electron microscopy of CTN from healthy ears and from ears
whit chronic otitis or cholesteatoma. We we plan to investigate samples from five
healthy and from five sick ears with EM.
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Observational Model: Cohort, Time Perspective: Prospective