Tympanic Membrane PerforationNCT03416725
Evaluation of Prognostic Factors in Tympanoplasty
An observational study of Tympanic Membrane Perforation, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- Otoscope
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: People with CSOM planning to make tympanoplasty
Who may be able to join
- patients of the age group 18-60 years with Chronic suppurative otitis media (CSOM) planned for tympanoplasty.
Who cannot join
- Patients with otomycosis, septic foci such as sinusitis which can influence the outcome of tympanoplasty were excluded from the study
About this study
Official title: 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.
Read the 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
- Being tested
- Otoscope
- Medical subject headings
- Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtoscopeDevice
Otoscopic examination will be done to find the presence or absence of perforation, granulation tissue and cholesteatoma.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic suppurative otitis media. | patients of the age group 18-60 years with Chronic suppurative otitis media (CSOM) planned for tympanoplasty. Receives: Device: Otoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start1 Mar 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tympanic Membrane PerforationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, asmaa.nabil, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416725
- Sponsor's protocol ID
- MERI
- Status last verified
- Jan 2018
- First submitted
- 12 Jan 2018
- Last updated
- 31 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kartush JM. Ossicular chain reconstruction. Capitulum to malleus. Otolaryngol Clin North Am. 1994 Aug;27(4):689-715.
PubMed 7984370Becvarovski 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.
PubMed 11801949WULLSTEIN H. Theory and practice of tympanoplasty. Laryngoscope. 1956 Aug;66(8):1076-93. doi: 10.1288/00005537-195608000-00008. No abstract available.
PubMed 13358259
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prognostic Factors and Middle Ear Risk Index in Tympanoplasty
- ClinicalTrials.gov ID
- NCT03416725
- Acronym / sponsor ID
- MERI
- Conditions
- Tympanic Membrane Perforation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic suppurative otitis media. | – | Device: Otoscopepatients of the age group 18-60 years with Chronic suppurative otitis media (CSOM) planned for tympanoplasty. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- People with CSOM planning to make tympanoplasty
Key inclusion criteria (1 listed)
- patients of the age group 18-60 years with Chronic suppurative otitis media (CSOM) planned for tympanoplasty.
Key exclusion criteria (1 listed)
- Patients with otomycosis, septic foci such as sinusitis which can influence the outcome of tympanoplasty were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OtoscopeOtoscopic examination will be done to find the presence or absence of perforation, granulation tissue and cholesteatoma. | Device | Patients with chronic suppurative otitis media. |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Background: PubMed 7984370Kartush JM. Ossicular chain reconstruction. Capitulum to malleus. Otolaryngol Clin North Am. 1994 Aug;27(4):689-715.
- Background: PubMed 11801949Becvarovski 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.
- Background: PubMed 13358259WULLSTEIN H. Theory and practice of tympanoplasty. Laryngoscope. 1956 Aug;66(8):1076-93. doi: 10.1288/00005537-195608000-00008. No abstract available.
Related trials for Tympanic Membrane Perforation
Not yet recruiting
Effect of Autologous Serum-Soaked Paper Patch vs. Traditional Dry Paper Patch on Tympanic Membrane Perforations
Tympanic Membrane Perforation
RecruitingObservational study
Bacteriological Evaluation of Children With Otorrhea
Otorrhea
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Not yet recruiting
Outcomes of Cartilage Tympanoplasty in Children
Tympanic Membrane Perforation, Conductive Hearing Loss
Not yet recruiting
Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results?
Tympanic Membrane Perforation, Otitis Media
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Tympanic Membrane Perforation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of prognostic factors in tympanoplasty to predict the outcome of the surgical management whenever done. (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03416725, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.