Clinical trial NCT03416725: Evaluation of Prognostic Factors in Tympanoplasty
Official title: Evaluation of Prognostic Factors and Middle Ear Risk Index in Tympanoplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tympanic Membrane Perforation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with CSOM planning to make tympanoplasty

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.

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

Eligibility 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

Primary outcomes:
measure: Evaluation of prognostic factors in tympanoplasty to predict the outcome of the surgical management whenever done.
timeFrame: One year
measure: Evaluation of middle ear risk index in tympanoplasty
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kartush JM. Ossicular chain reconstruction. Capitulum to malleus. Otolaryngol Clin North Am. 1994 Aug;27(4):689-715.
citation: 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.
citation: WULLSTEIN H. Theory and practice of tympanoplasty. Laryngoscope. 1956 Aug;66(8):1076-93. doi: 10.1288/00005537-195608000-00008. No abstract available.