deafness
Conditions
Interventions
126 patients were randomized in two groups for cochlear implant surgery. Cases (n:63) underwent simple mastoidectomy using an anteriorly pedicled osteoplastic flap for mastoid closure. In controls (n:
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Sponsors
Faculdade de Medicina da Universidade de São Paulo
Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to 72 Years
Inclusion criteria
Inclusion criteria: Patients 18 years or older, with normal mastoid and middle ear anatomy assessed by computed tomography exams, who undergo cochlear implant surgery at University of São Paulo Hospital das Clinicas.
Exclusion criteria
Exclusion criteria: Acute or chronic otitis media at the time of surgery, computed tomography exam or wideband tympanometry; - Patients with the following tomographic changes in the preoperative period: o sigmoid sinus displaced laterally or posteriorly towards the cortical of the mastoid and prominent; o malformation of the inner and/or middle ear; - Deafness due to cranial trauma or temporal bone fracture; - Diagnosis of chronic serous otitis media with an otoscopy showing retrotympanic secretion in the preoperative or intraoperative period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study analyzed a proposal for a new osteoplastic flap with an anterior pedicle, composed of bone, muscle and periosteum, autologous, easy to handle, readily available during surgery. In addition, it is more economically viable when compared to heterologous grafts, as it does not involve extra costs and there is no possibility of a foreign body reaction. We compared the results of the quality of the surgical wound by Introduction of this technique taking advantage of the traditional technique of opening and closing a simple mastoidectomy, without an infectious process, and for this reason, a bolognese to be performed in cochlear implant surgery. The comparison between the techniques made it possible to assess, in addition to the patient's aesthetic satisfaction and the examiner's perception of the quality of the surgical wound, the impact of surgery on maintaining mastoid aeration by means of computed tomography examination of the temporal bones and its influence on physiology of the middle ear, through the examination of broadband tympanometry. During simple mastoidectomy to insert the cochlear implant, a proposal to reconstruct the mastoid bone defect generated in the cortical opening of the mastoid aims to prevent retroauricular cosmetic deformity and the growth of fibrous tissue into the surgical cavity, in addition to maintaining the mastoid and tympanic cavity. pneumatized over the long term, which can reduce the chance of developing an inflammatory or infectious process such as secretory otitis.;degree of aesthetic satisfaction with the quality of the surgical wound, measured by the sum of the POSAS questionnaire, with 1 being the score that means the closest to normal skin and> 1 to 10 tgrade the abnormal variation in the quality of the wound, being worse the rating the higher the grade. | — |
Secondary
| Measure | Time frame |
|---|---|
| to evaluate the volume of aeration of the mastoid cavity after a period longer than one year after surgery, using three-dimensional volumetric measurement with computed tomography exam applied to both surgical techniques: traditional and with the proposed new flap.;to evaluate whether the influence of the mastoid aeration volume influences the sound absorption values ??in the middle ear with each surgical technique employed, using the wideband timpanometry test for measurement: in the traditional technique and the new proposal of osteoplastic flap for opening and closing the mastoid cavity, also after a period greater than 1 year the surgery is performed. | — |
Countries
Brazil
Contacts
Public Contactpaula lopes
Outcome results
None listed