Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy

NCT ID: NCT03294421

Last Updated: 2020-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-22
• Study Completion Date: 2020-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard closed tympanomastoidectomy

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

Group Type: ACTIVE_COMPARATOR

standard closed tympanomastoidectomy

Intervention Type: PROCEDURE

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

combined access tympanomastoidectomy

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.

Group Type: EXPERIMENTAL

combined access tympanomastoidectomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sady S Da costa

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Mauricio LS Da silva

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de clínicas de porto alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

Paparella MM. Current concepts in otitis media. Henry Ford Hosp Med J. 1983;31(1):30-6. No abstract available.

Reference Type: BACKGROUND

PMID: 6863004 (View on PubMed)

Ghaffar S, Ikram M, Zia S, Raza A. Incorporating the endoscope into middle ear surgery. Ear Nose Throat J. 2006 Sep;85(9):593-6.

Reference Type: BACKGROUND

PMID: 17044426 (View on PubMed)

Lima Tde O, Araujo TF, Soares LC, Testa JR. The impact of endoscopy on the treatment of cholesteatomas. Braz J Otorhinolaryngol. 2013 Aug;79(4):505-11. doi: 10.5935/1808-8694.20130090.

Reference Type: BACKGROUND

PMID: 23929154 (View on PubMed)

Badr-El-Dine M, James AL, Panetti G, Marchioni D, Presutti L, Nogueira JF. Instrumentation and technologies in endoscopic ear surgery. Otolaryngol Clin North Am. 2013 Apr;46(2):211-25. doi: 10.1016/j.otc.2012.10.005.

Reference Type: BACKGROUND

PMID: 23566907 (View on PubMed)

Marchioni D, Soloperto D, Rubini A, Villari D, Genovese E, Artioli F, Presutti L. Endoscopic exclusive transcanal approach to the tympanic cavity cholesteatoma in pediatric patients: our experience. Int J Pediatr Otorhinolaryngol. 2015 Mar;79(3):316-22. doi: 10.1016/j.ijporl.2014.12.008. Epub 2015 Jan 7.

Reference Type: BACKGROUND

PMID: 25631934 (View on PubMed)

Other Identifiers

50571215.0.0000.5327

Identifier Type: -

Identifier Source: org_study_id