Evaluation of Prognostic Factors in Tympanoplasty

January 24, 2018 updated by: asmaa.nabil, Assiut University

Evaluation of Prognostic Factors and Middle Ear Risk Index in Tympanoplasty

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People with CSOM planning to make tympanoplasty

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Otoscopic examination will be done to find the presence or absence of perforation, granulation tissue and cholesteatoma.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of prognostic factors in tympanoplasty to predict the outcome of the surgical management whenever done.
Time Frame: One year
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
Time Frame: One year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MERI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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