abnormal noncancerous growth of skin cells that forms behind the eardrum
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - The patient is willing to participate and has provided written informed consent authorization before participating in the study - The patient is >=18 years of age at the time of consent - The patient has sufficient understanding of the Dutch written language - The health status of the patient allows general anaesthesia and surgery for the removal of a cholesteatoma - The patient is eligible to undergo a CWU tympanomastoidectomy approach based on the clinical and/or radiological suspicion for a cholesteatoma. Patients should only be included when the surgeon deems a transcanal approach not feasible and that, therefore, a mastoidectomy is necessary based on the pre-operative assessment. - The patient is covered by a health insurance company
Exclusion criteria
Exclusion criteria: - Cases of revision surgery due to residual disease with a normal, intact or reconstructed tympanic membrane - Cases where a previous obliteration has taken place - Cases of congenital cholesteatoma - Patient with an indication for the surgery due to a disease other than cholesteatoma (chronic otitis media) - In rare cases patients may have a pathology which makes obliteration unavoidable due to the invasiveness of the disease (e.g. cholesteatoma extension into and near total destruction of the bony ear canal or bony tegmen plate). This is judged by the treating physician. - Severe comorbidity with an expected survival of less than five years - Comorbidity or disorder which could interfere with the completion of questionnaires (e.g. known psychiatric disorder, mental retardation) - Compromising anatomical situation (i.e. radical cavity, Congenital craniofacial anomalies with involvement of the temporal bone and including cleft palate) - Contraindication to undergo a diffusion-weighted magnetic resonance imaging (DW-MRI) (e.g. claustrophobic, metal parts of implants in the body such as a pacemaker)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of recurrent or residual cholesteatoma are evaluated by diffusion-weighted magnetic resonance imaging (DW-MRI) and micro-otoscopy after approximately one, three and five years. If diffusion restriction is seen on DW-MRI and/or retraction of the tympanic membrane is seen during micro-otoscopy, suspicion for recurrent or residual disease will be recorded. To confirm the diagnosis and to determine whether the cholesteatoma is either recurrent or residual, we will analyse the tympanic membrane description at the beginning of the revision surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| All other surgical outcome measures are recorded in the surgical report. Pure tone audiograms, including air and bone conduction, and speech recognition scores are evaluated pre- and postoperatively for each patient. The EQ-5D-5L, HUI-3, iMCQ and iPCQ questionnaires will be filled in once pre- and a two times postoperatively by every patient. The OQUA will be filled in once preoperatively and three times postoperatively. The direct health-care costs will be recorded for the sponsor centre and extrapolated for the whole trial. | — |
Countries
Netherlands
Outcome results
None listed