Chronic Otitis Media Clinical Trial
Official title:
Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy
Chronic otitis media is a prevalent medical condition, leading to important impact in the
lives of the individuals with this condition, and a great amount of patients may need
surgical intervention. The main objectives of the surgery in these cases are to restore the
anatomy of the middle ear, to improve hearing and to remove the infection to avoid further
complications. Still, chronic otitis media with cholesteatoma presents high rates of
recurrence and residual symptoms after surgery.
The standard technique used for treatment of chronic otitis media is microsurgery.
Nonetheless, with the development of new technologies that use endoscopy, it is now possible
to use endoscopic surgery to improve the visualization of the cholesteatoma and ear
structures by combining both techniques.
This study will evaluate the efficacy of the combined access surgery technique, which is
microsurgery combined with endoscopy, for closed tympanomastoidectomy in patients with
cholesteatoma. Furthermore, the study aims to compare the results of the combined access
technique and the standard technique by randomizing the patients in two groups: one group
will receive tympanomastoidectomy by standard technique and the other group will receive
combined technique.
Patients with cholesteatoma and medical indication of closed tympanomastoidectomy will be
randomized into two groups. In the first group, microsurgical tympanomastoidectomy will be
performed; while combined technique will be performed in the other group. The combined
technique improves the visualization of the middle ear canal and the mastoid. Herewith, the
best visualization of the surgical site facilitates the full removal of the cholesteatoma. In
addition to that, the combined technique is less invasive than the standard one, since less
bone debridement is required to access the surgical site.
The outcomes of the study will be evaluated through follow up medical appointments and exams.
The patients will be followed by monthly medical appointments with otoscopic evaluations for
diagnose of possible recurrence of the disease or residual cholesteatoma. Also, audiometry
exams will be performed in the third, sixth and twelfth months. Image exams such as nuclear
magnetic resonance may be performed at the end of this period to evaluate relapse of the
disease if the otoscopic evaluation is inconclusive.
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