NCT03416725

Evaluation of Prognostic Factors in Tympanoplasty

Evaluation of Prognostic Factors and Middle Ear Risk Index in Tympanoplasty

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: —

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.

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

Conditions

• Tympanic Membrane Perforation

Interventions

Type	Name	Description
DEVICE	Otoscope	Otoscopic examination will be done to find the presence or absence of perforation, granulation tissue and cholesteatoma.

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-03-01
• Completion: 2020-03-01
• First posted: 2018-01-31
• Last updated: 2018-01-31