Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: Chronic Otitis Media; Cholesteatoma

Treatments: Procedure: combined access tympanomastoidectomy; Procedure: standard closed tympanomastoidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03294421

50571215.0.0000.5327

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 64 patients

Sex: All

Ages: 5 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with cholesteatoma with indication for closed tympanomastoidectomy.

Exclusion criteria

• Patients with malformation of the temporal bone or previous surgery in the ear eligible for the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

standard closed tympanomastoidectomy

Active Comparator group

Description:

In this group it will be performed the standard technique for closed tympanomastoidectomy, in which a surgical microscope is used.

Treatment:

Procedure: standard closed tympanomastoidectomy

combined access tympanomastoidectomy

Experimental group

Description:

In this group a closed tympanomastoidectomy with combined access will be performed. This technique combines the use of a surgical microscope with a rigid endoscope measuring 14cm of length with 0º and 30º angulation.

Treatment:

Procedure: combined access tympanomastoidectomy