Evaluation of Prognostic Factors in Tympanoplasty

Tympanic Membrane Perforation Clinical Trial

Official title:

Evaluation of Prognostic Factors and Middle Ear Risk Index in Tympanoplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03416725
• Other study ID #: MERI
• Status: Not yet recruiting
• Phase: N/A
• First received: January 12, 2018
• Last updated: January 24, 2018
• Start date: March 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: January 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2019
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Tympanic Membrane Perforation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Becvarovski Z, Kartush JM. Smoking and tympanoplasty: implications for prognosis and the Middle Ear Risk Index (MERI). Laryngoscope. 2001 Oct;111(10):1806-11. — View Citation

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

WULLSTEIN H. Theory and practice of tympanoplasty. Laryngoscope. 1956 Aug;66(8):1076-93. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of prognostic factors in tympanoplasty to predict the outcome of the surgical management whenever done.	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.	One year
Primary	Evaluation of middle ear risk index in tympanoplasty	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	One year