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Evaluation of Prognostic Factors in Tympanoplasty

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ClinicalTrials.gov Identifier: NCT03416725
Recruitment Status : Unknown
Verified January 2018 by asmaa.nabil, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
asmaa.nabil, Assiut University

Brief Summary:

Tympanoplasty is the surgical operation performed for the reconstruction of the eardrum and/or the ossicles. Tympanoplasty is classified into five different types, originally described by Horst Ludwig Wullstein. 1,2 Type 1 involves repair of the tympanic membrane alone, when the middle ear is normal. A type 1 tympanoplasty is synonymous to myringoplasty, Type 2 involves repair of the tympanic membrane and middle ear in spite of slight defects in the middle ear ossicles, Type 3 when mallus and incus are absent graft place directly on stapes head., Type 4 describes a repair when the stapes foot plate is movable, but the crura are missing. The resulting middle ear will only consist of the Eustachian tube and hypotympanum, Type 5 is a repair involving a fixed stapes footplate.

There are various prognostic factors reported in the literature that may influence the surgical success of tympanoplasty.


Condition or disease Intervention/treatment
Tympanic Membrane Perforation Device: Otoscope

Detailed Description:

Some studies report significance for some of these factors whereas others report the contrary. The reported incidence of surgical success of tympanoplasty ranges from 60% to 99% in adults Belluci described four separate stages for prognosis of tympanoplasty 4 according to otorrhea

. Austin proposed a prognostic stratification according to disease categories, stage categories, and disease descriptors.

Black introduced the surgical, prosthetic, infection, tissues, and eustachian tube system (SPITE), and more recently Kartush developed middle ear risk index (MERI).

Smoking is added as a middle ear risk. Furthermore, cholesteatoma and granulation tissue or effusion risk value has been increased in MERI 2001.

Prognostic factors such as age, sex, presence of systemic diseases, location and size of perforation, duration of dry period, presence of myringosclerosis, presence of septal and conchal pathology, operation type, and status of the opposite ear and middle ear risk index were investigated. 9

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Prognostic Factors and Middle Ear Risk Index in Tympanoplasty
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2020

Group/Cohort Intervention/treatment
Patients with chronic suppurative otitis media.
patients of the age group 18-60 years with Chronic suppurative otitis media (CSOM) planned for tympanoplasty.
Device: Otoscope
Otoscopic examination will be done to find the presence or absence of perforation, granulation tissue and cholesteatoma.




Primary Outcome Measures :
  1. Evaluation of prognostic factors in tympanoplasty to predict the outcome of the surgical management whenever done. [ Time Frame: One year ]
    Prognostic factors such as age, sex, presence of systemic diseases, location and size of perforation, duration of dry period, presence of myringosclerosis, presence of septal and conchal pathology and status of the opposite ear and middle ear risk index will be investigated.

  2. Evaluation of middle ear risk index in tympanoplasty [ Time Frame: One year ]
    Each risk parameter will take a numerical value; Ear discharge: 0-3, Perforation: 0-2, Cholesteotoma: 0-2, Ossicular chain status: 0-4, Middle ear granulation and history of previous surgery: 0-2. Now newly, smoking is also included as a risk parameter. The MERI will be evaluated. The patients will be categorized into those with mild (0-3), moderate(4-6) and severe(≥7) MERI



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
People with CSOM planning to make tympanoplasty
Criteria

Inclusion Criteria:

  • patients of the age group 18-60 years with Chronic suppurative otitis media (CSOM) planned for tympanoplasty.

Exclusion Criteria:

  • Patients with otomycosis, septic foci such as sinusitis which can influence the outcome of tympanoplasty were excluded from the study
Publications:
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Responsible Party: asmaa.nabil, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03416725    
Other Study ID Numbers: MERI
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

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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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Tympanic Membrane Perforation
Ear Diseases
Otorhinolaryngologic Diseases
Wounds and Injuries