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.

Study Overview

• Status: Unknown
• Conditions: Cholesteatoma; Chronic Otitis Media
• Intervention / Treatment: Procedure: standard closed tympanomastoidectomy; Procedure: combined access tympanomastoidectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
      • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 88 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard closed tympanomastoidectomy; In this group it will be performed the standard technique for closed tympanomastoidectomy, in which a surgical microscope is used.	Procedure: standard closed tympanomastoidectomy; Supine position and general anesthesia with orotracheal intubation; Antisepsis and placing of sterile fields; Local anesthesia of the external auditory canal with lidocaine 2% and adrenaline 1:100. 000 UI; Retroauricular incision; Removal of the temporal muscle fascia; Elevation of the surgical flap of the tympanic meatus; Visualization and exploration of the cholesteatoma; Exploration of the ossicular chain; Mastoid debridement; Conservation of the upper posterior wall of the auditory conduct; Removal of the cholesteatoma; Tympanoplasty with the temporal fascia; Retroauricular suture with vycril 3.0 and mononylon 4.0
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of cholesteatoma.	Recurrence of cholesteatoma, which is defined as development of new disease in the same ear (not related with the previous cholesteatoma), will be evaluated through second look surgery or nuclear magnetic resonance.	12 months post intervention.
Residual cholesteatoma	Presence of residual cholesteatoma, which is defined as disease that was not fully removed in the first intervention, will be evaluated through second look surgery or nuclear magnetic resonance.	12 months post intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing outcomes	Hearing outcomes will be measured through audiometry exams (parameters that will be analyzed in the exam: Pure tone average (PTA) 500.000 Hz to 2.000 Hz and air bone gap) after three months after surgery and compared with the audiometry exam made before the surgery.	3 months post intervention.
Hearing outcomes	Hearing outcomes will be measured through audiometry exams (parameters that will be analyzed in the exam: PTA 500.000 Hz to 2.000 Hz and air bone gap) after six months after surgery and compared with the audiometry exam made before the surgery and the audiometry exam made three months after surgery.	6 months post intervention.
Hearing outcomes	Hearing outcomes will be measured through audiometry exams (parameters that will be analyzed in the exam: PTA 500.000 Hz to 2.000 Hz and air bone gap) after twelve months after surgery and compared with the audiometry exam made before the surgery and the audiometry exams made three and six months after surgery.	12 months post intervention.
Length of procedure	Compares the length of the closed tympanomastoidectomy with standard technique and the combined access tympanomastoidectomy.	measured in minutes from the surgical incision until the suture of the skin.

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Sady S Da costa, Hospital de Clinicas de Porto Alegre; Principal Investigator: Mauricio LS Da silva, Hospital de Clinicas de Porto Alegre

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2017
• Primary Completion (Actual): May 7, 2020
• Study Completion (Anticipated): August 31, 2020

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: September 4, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Keratosis; Otitis Media; Cholesteatoma
• Other Study ID Numbers: 50571215.0.0000.5327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No