The primary aim of this study is to investigate whether a canal wall up (CWU) tympanomastoidectomy with obliteration of the mastoid and paratympanic or epitympanic spaces reduces cholesteatoma recurrence and residual rates compared to the same…
ID
Source
Brief title
Condition
- Middle ear disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The mainstay of cholesteatoma treatment is surgery with effective and safe
removal of the disease as the principal goal. New techniques find their way in
the international otologic community by proving lower recurrent and residual
disease rates compared to the conventional techniques. One newly implemented
and previously described technique is the obliteration technique of the mastoid
and epitympanum. Although this approach has become more popular in recent
years, high-quality evidence is missing.
Study objective
The primary aim of this study is to investigate whether a canal wall up (CWU)
tympanomastoidectomy with obliteration of the mastoid and paratympanic or
epitympanic spaces reduces cholesteatoma recurrence and residual rates compared
to the same approach without obliteration. Secondarily, hearing outcomes after
both surgical techniques are compared to investigate whether one of the two
results in superior postoperative hearing. The quality of life will be measured
using the Otology Questionnaire Amsterdam (OQUA). The economic evaluation will
involve collecting the intervention costs from the sponsoring centre and
extrapolating them to the entire trial.
Study design
The proposed study is a single-blind randomized controlled trial. Patients are
randomized into one of two groups in an equal 1:1 allocation ratio. The
randomization will be centre-stratified and a 4,6,8 block randomization will be
used.
Study burden and risks
The burden patients will experience by participating in this study will be
filling in the questionnaire multiple times. The surgery, along with the
imaging procedures (CT and DW-MRI), audiometry and follow-up appointments, is
part of standard care and takes place irrespective of participation in this
study.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
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
- 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
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 | NL86362.041.24 |