NCT03416725

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

January 12, 2018

Last Update Submit

January 24, 2018

Conditions

Tympanic Membrane Perforation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

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

Interventions

OtoscopeDEVICE

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

Patients with chronic suppurative otitis media.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

People with CSOM planning to make tympanoplasty

You may qualify if:

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

You may not qualify if:

  • Patients with otomycosis, septic foci such as sinusitis which can influence the outcome of tympanoplasty were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

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

    PMID: 7984370BACKGROUND

  • 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.

    PMID: 11801949BACKGROUND

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

    PMID: 13358259BACKGROUND

MeSH Terms

Conditions

Tympanic Membrane Perforation

Interventions

Otoscopes

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and Supplies

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 31, 2018

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2020

Last Updated

January 31, 2018

Record last verified: 2018-01