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Evaluation of Prognostic Factors in Tympanoplasty

NCT ID: NCT03416725

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-03-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Tympanic Membrane Perforation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with chronic suppurative otitis media.

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

Otoscope

Intervention Type DEVICE

Otoscopic examination will be done to find the presence or absence of perforation, granulation tissue and cholesteatoma.

Interventions

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Otoscope

Otoscopic examination will be done to find the presence or absence of perforation, granulation tissue and cholesteatoma.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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asmaa.nabil

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Kartush JM. Ossicular chain reconstruction. Capitulum to malleus. Otolaryngol Clin North Am. 1994 Aug;27(4):689-715.

Reference Type BACKGROUND
PMID: 7984370 (View on PubMed)

Becvarovski Z, Kartush JM. Smoking and tympanoplasty: implications for prognosis and the Middle Ear Risk Index (MERI). Laryngoscope. 2001 Oct;111(10):1806-11. doi: 10.1097/00005537-200110000-00026.

Reference Type BACKGROUND
PMID: 11801949 (View on PubMed)

WULLSTEIN H. Theory and practice of tympanoplasty. Laryngoscope. 1956 Aug;66(8):1076-93. doi: 10.1288/00005537-195608000-00008. No abstract available.

Reference Type BACKGROUND
PMID: 13358259 (View on PubMed)

Other Identifiers

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MERI

Identifier Type: -

Identifier Source: org_study_id