To investigate which surgical technique (with or without vein graft interposition) is most (cost-)effective in patients with otosclerosis in terms of the average postoperative air-bone gap (ABG) closure, individual air and bone conduction thresholds…
ID
Source
Brief title
Condition
- Middle ear disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be postoperative hearing improvement in terms of the
average ABG closure 12 months after surgery.
Secondary outcome
-Postoperative average air-bone gap closure (dB), after 3 and 6 months.
-Bone conduction thresholds at 0.5, 1, 2, 3 and 4 kHz, after 3, 6 and 12 months.
-Air conduction thresholds at 0.5, 1, 2, 3 and 4 kHz, after 3, 6 and 12 months.
-Air bone gap at 0.5, 1, 2, 3 and 4 kHz, after 3, 6 and 12 months.
-Postoperative complications, after 3, 6 and 12 months:
-Tinnitus
-Vertigo
-Dizziness
-Postoperative sensorineural hearing loss (cochlear damage)
-*Dead ear* (total deafness after surgery)
-Subjective patient*s perception, after 3, 6 and 12 months.
-Quality of Life, after 3, 6 and 12 months.
-Spending/costs-log, after 3, 6 and 12 months.
Background summary
Otosclerosis is characterized by a deposit of new spongy bone around the stapes
footplate, resulting in stapes fixation. The stapes is a vital link of the
noise conduction system and fixation leads to hearing impairment. Replacement
of the affected stapes with prosthesis is an effective method to achieve
hearing improvement. Different surgical techniques are available. One technique
applies a vein graft, harvested from the back of the patient*s hand. The vein
graft is placed beneath the prosthesis. Available literature suggests that a
vein graft may increase postoperative hearing results, compared to prosthesis
without vein graft. However, up to now no randomised controlled trials have
been performed to compare both methods. Stapes surgery without vein graft is
therefore still the standard technique in most otologic institutions.
Study objective
To investigate which surgical technique (with or without vein graft
interposition) is most (cost-)effective in patients with otosclerosis in terms
of the average postoperative air-bone gap (ABG) closure, individual air and
bone conduction thresholds, postoperative complications (tinnitus, vertigo,
sensorineural hearing loss), postoperative subjective patient*s perception and
postoperative quality of life.
Study design
A multicenter Randomised Controlled Trial including 180 patients with primary
otosclerosis.
Intervention
Stapes surgery, with and without a vein graft beneath the prosthesis.
Study burden and risks
Both interventions carry the usual risks associated with surgery, i.e. pain,
wound infection. Usual risks, associated with stapes surgery are tinnitus,
vertigo, sensorineural hearing loss, taste complaints, a tympanic membrane
perforation and facial nerve complaints. In the vein graft group the
anaesthetic period might be slightly longer due to vein graft harvesting from
the back of the hand.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
-Age >= 18 years
-Otosclerosis, diagnosed by an ear, nose and throat specialist in Utrecht or Hannover
-Primary otosclerosis
-Mean ABG >20 dB based on the ABG values at 0.5, 1, 2, and 4 kHz
-Willingness and ability to participate in all scheduled procedures
-General health allowing general anaesthesia for the potential stapes surgery
Exclusion criteria
-Age < 18 years
-Previous middle-ear surgery
-Co-morbidities: pregnancy, osteogenesis imperfecta, other middle- or inner-ear pathology (besides otosclerosis) In case of chronic/active ear infection in one or both ears; first treatment of this infection
-Abnormal anatomy in one or both ears
-Disability which could interfere with audiologic measurements or questionnaire fulfilment
-Inability or unwillingness to participate in the follow-up procedures
Design
Recruitment
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 | NL31170.041.10 |