NCT03294421

Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 5 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Cholesteatoma
• Chronic Otitis Media

Interventions

Type	Name	Description
PROCEDURE	combined access tympanomastoidectomy	Trans canal surgery with the use of a surgical microscope with a rigid endoscope measuring 14cm of length with 0º and 30º angulation allowing better visualization and removal of the cholesteatoma before mastoid debridement. In this surgery, mastoid debridement is conducted only if there was no full endoscopic removal of the cholesteatoma. The other procedures of this type of surgery are similar to the standard tympanomastoidectomy technique.
PROCEDURE	standard closed tympanomastoidectomy	1. Supine position and general anesthesia with orotracheal intubation 2. Antisepsis and placing of sterile fields 3. Local anesthesia of the external auditory canal with lidocaine 2% and adrenaline 1:100. 000 UI 4. Retroauricular incision 5. Removal of the temporal muscle fascia 6. Elevation of the surgical flap of the tympanic meatus 7. Visualization and exploration of the cholesteatoma 8. Exploration of the ossicular chain 9. Mastoid debridement 10. Conservation of the upper posterior wall of the auditory conduct 11. Removal of the cholesteatoma 12. Tympanoplasty with the temporal fascia 13. Retroauricular suture with vycril 3.0 and mononylon 4.0

Timeline

• Start date: 2017-09-22
• Primary completion: 2020-05-07
• Completion: 2020-08-31
• First posted: 2017-09-27
• Last updated: 2020-09-07

Locations

1 site across 1 country: Brazil