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Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03294421
Recruitment Status : Unknown
Verified April 2017 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : September 27, 2017
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.


Condition or disease Intervention/treatment Phase
Cholesteatoma Chronic Otitis Media Procedure: combined access tympanomastoidectomy Procedure: standard closed tympanomastoidectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy
Actual Study Start Date : February 1, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


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
  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

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.




Primary Outcome Measures :
  1. Recurrence of cholesteatoma. [ Time Frame: 12 months post intervention. ]
    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.

  2. Residual cholesteatoma [ Time Frame: 12 months post intervention. ]
    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.


Secondary Outcome Measures :
  1. Hearing outcomes [ Time Frame: 3 months post intervention. ]
    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.

  2. Hearing outcomes [ Time Frame: 6 months post intervention. ]
    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.

  3. Hearing outcomes [ Time Frame: 12 months post intervention. ]
    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.

  4. Length of procedure [ Time Frame: measured in minutes from the surgical incision until the suture of the skin. ]
    Compares the length of the closed tympanomastoidectomy with standard technique and the combined access tympanomastoidectomy.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294421


Contacts
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Contact: Sady S Da costa 555133376090 ext 5587 selaimen@gmail.com
Contact: Mauricio LS Da silva 5551999749420 noschangmauricio@gmail.com

Locations
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Brazil
Hospital de clínicas de porto alegre Recruiting
Porto Alegre, Rio grande do sul, Brazil, 90035903
Contact: Sady S Da costa    555133376090 ext 5587    selaimen@gmail.com   
Contact: Mauricio LS Da silva    5551999749420    noschangmauricio@gmail.com   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Sady S Da costa Hospital de clínicas de Porto Alegre
Principal Investigator: Mauricio LS Da silva Hospital de clínicas de Porto Alegre
Publications:
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03294421    
Other Study ID Numbers: 50571215.0.0000.5327
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Otitis Media
Cholesteatoma
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Keratosis
Skin Diseases