NCT03294421

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

September 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

September 7, 2020

Status Verified

September 1, 2020

Enrollment Period

2.6 years

First QC Date

September 8, 2017

Last Update Submit

September 4, 2020

Conditions

CholesteatomaChronic Otitis Media

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Hearing outcomes

    3 months post intervention.

  • Hearing outcomes

    6 months post intervention.

  • Hearing outcomes

    12 months post intervention.

  • Length of procedure

    measured in minutes from the surgical incision until the suture of the skin.

Study Arms (2)

standard closed tympanomastoidectomy

ACTIVE COMPARATOR

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

Procedure: standard closed tympanomastoidectomy

combined access tympanomastoidectomy

EXPERIMENTAL

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

Interventions

combined access tympanomastoidectomyPROCEDURE

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.

combined access tympanomastoidectomy
standard closed tympanomastoidectomyPROCEDURE

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

standard closed tympanomastoidectomy

Eligibility Criteria

Age5 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with cholesteatoma with indication for closed tympanomastoidectomy.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de clínicas de porto alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Related Publications (5)

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

    PMID: 6863004BACKGROUND

  • 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.

    PMID: 17044426BACKGROUND

  • 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.

    PMID: 23929154BACKGROUND

  • 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.

    PMID: 23566907BACKGROUND

  • 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.

    PMID: 25631934BACKGROUND

MeSH Terms

Conditions

Cholesteatoma

Condition Hierarchy (Ancestors)

KeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sady S Da costa

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

  • Mauricio LS Da silva

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 27, 2017

Study Start

September 22, 2017

Primary Completion

May 7, 2020

Study Completion

August 31, 2020

Last Updated

September 7, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)