Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy

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.

Conditions

• Cholesteatoma
• Chronic Otitis Media

Interventions

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre

  lead OTHER

Principal Investigators

• Sady S Da costa · Hospital de Clínicas de Porto Alegre

• Mauricio LS Da silva · Hospital de Clínicas de Porto Alegre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-22

Primary Completion

2020-05-07

Completion

2020-08-31

Countries

• Brazil

Study Locations