Primary Objective:To evaluate the effect of CTN injury on postoperative taste function measured using taste strips in patients undergoing primary stapes surgery or primary cochlear implantation. Secondary Objective(s):- To compare the postoperative…
ID
Source
Brief title
Condition
- Middle ear disorders (excl congenital)
- Procedural related injuries and complications NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the 6 weeks postoperative amount of identified
taste strips of the ipsilateral tongue of the operated ear. The range for
possible scores is 0 to 20.
Secondary outcome
- The difference between the preoperative and postoperative amount of
identified sweet taste strips of the ipsilateral tongue of the operated ear
- The difference between the preoperative and postoperative amount of
identified salty taste strips of the ipsilateral tongue of the operated ear
- The difference between the preoperative and postoperative amount of
identified sour taste strips of the ipsilateral tongue of the operated ear
- The difference between the preoperative and postoperative amount of
identified bitter taste strips of the ipsilateral tongue of the operated ear
- The difference between the preoperative and postoperative amount of
identified umami taste strips of the ipsilateral tongue of the operated ear
The difference between the preoperative and postoperative EGM thresholds in dB
for different locations of the tongue
- The postoperative existence of metallic taste sensation
- The postoperative existence of dryness of the mouth
- The postoperative existence of tingling sensations of the tongue
- The postoperative existence of numbness of the tongue
- The difference between the preoperative and postoperative score of the AHSP
questionnaire- The difference between the preoperative and postoperative score
of the health-related quality of life questionnaire
- The difference between the preoperative and postoperative total and sub
scores of the MTPRT
- The difference between the preoperative and postoperative odour
identification score
Background summary
The chorda tympani nerve (CTN) is a mixed nerve, which carries sensory and
parasympathetic fibers. The sensory component supplies the taste sensation of
the anterior two-thirds of the ipsilateral side of the tongue. During middle
ear surgery the CTN is exposed and frequently stretched or sacrificed, because
it lacks a bony covering as it passes the middle ear. The injury may cause
hypogeusia, ageusia or altered taste sensation of the ipsilateral side of the
tongue. Patients may also suffer from a dry mouth. To date, there is no
consensus regarding which type of CTN injury, obtained during primary stapes
surgery and primary cochlear implantation, gives the least burden.
Study objective
Primary Objective:
To evaluate the effect of CTN injury on postoperative taste function measured
using taste strips in patients undergoing primary stapes surgery or primary
cochlear implantation.
Secondary Objective(s):
- To compare the postoperative taste function of sweet, sour, bitter, salty and
umami measured using taste strips in patients between two types of CTN injury
(stretching or sacrificing)
- To compare the postoperative EGM threshold in dB for different locations of
the tongue in patients between two types of CTN injury (stretching or
sacrificing)
- To compare the presence of postoperative symptoms of taste disturbance in
patients between two types of CTN injury (stretching or sacrificing).
- To compare the postoperative perception of appetite, hunger and sensory in
patients between two types of CTN injury (stretching or sacrificing).
- To compare the postoperative quality of life in patients between two types of
CTN injury (stretching or sacrificing).
- To compare the postoperative enjoyment of food in patients between two types
of CTN injury (stretching or sacrificing).
- To compare the postoperative food preference in patients between two types of
CTN injury (stretching or sacrificing).
- To compare the postoperatieve odour identification score in patients between
two types of CTN injury (stretching or sacrificing)
Study design
The study design is illustrated in Figure 1 of the protocol: C1. Patients
participate after Informed Consent (IC) is obtained. This is a prospective
multicemter study. It will run for approximately four years in the UMCU and
Deventer Hospital. Evaluation will take place preoperatively and at 1 week, 6
weeks and 6 months postoperatively by means of taste strip test (TST),
electrogustometer (EGM), Macronutrient and Taste Preference Ranking Task
(MTPRT) and questionnaires. Preoperatively and 1 week postoperatively the
patient*s olfactory function will be evaluated using the Sniffin* Sticks test.
Three months after surgery the taste sensation is evaluated at home using
questionnaires.
Study burden and risks
Patients will not experience any risks during participation in the study. There
will be four test sessions. Each time, all participants complete two taste
tests and a macronutrient an taste preference ranking task and fill out several
sets of questionnaires. The test sessions will take place in the University
Medical Center Utrecht during the regular visits of the patient to the
hospital. Three months after surgery the taste sensation is evaluated at home
using questionnaires.The study burn is moderate. We believe that the burden is
in proportion to the potential value of the research.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Signed informed consent form
- Age >= 18 years
- Patients who are planned to undergo primary stapes surgery or primary
cochlear implantation
- Willingness and ability to participate in all scheduled procedures outlined
in the research protocol
- Good understanding of the Dutch language
Exclusion criteria
- Previous middle ear surgery (with the exception of the placement of
ventilation tubes in childhood)
- History of chemotherapy and/or radiotherapy
- History of facial nerve palsy
- Cardiac pacemaker
- Disability that could interfere with taste evaluation and/or questionnaire
fulfilment
- Pregnancy
- History of orofacial pain
- History of dysesthesia in the orofacial region
- Local evidence of a pathological condition of the oral mucosa
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76749.041.21 |