- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05229380
Pretympanoplasty Assessment of Patency and Mucociliary Function of Eustachian Tube
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Full history taking, general and Complete otolaryngology examination to ride at any pathologies and focus of infection which could influence the result of tympanoplasty.
- Audiological evaluation will be done for all patients both preoperatively and postoperatively
- Computed Tomography scanning of the mastoids will be done for all cases to rule out mastoiditis of any type
- Otoscopic examination size and site of perforation will be noted. The condition of middle ear mucosa, annulus, handle of malleus, and remnant of tympanic membrane (TM) will also be noted.
- Diagnostic Nasal Endoscopy: detailed nasal examination will be carried out. The nasal findings and the condition of the ET orifice will be noted.
- Saccharin test : Within two weeks before the surgery, the test will be performed. First, the taste response of patient to saccharin solution will br tested. With the patient seated and head tilted to the other ear , two drop of sterile sweety saccharin solution (one teaspoon saccharin granules dissolved in 10 ml sterile water) will placed in the middle ear through the TM defect by a dropper. The time required for the patient to taste the saccharin (ie, saccharin perception time [SPT]) will then measured.
- Methylene Blue Test: Within two weeks before the surgery, the test will be performed. The nose is first prepared by applying a nasal pack soaked in a solution composed of mixture of xylometazoline hydrchloride 0.1% and xylocaine 10% (1:1) for 10 minutes. Then 0- degree sinscope (Karl storz, Germany) will passed through the nose till an adequate view of the nasopharyngeal opening of the ET is obtained. Two to three drops of sterile methylene blue dye will placed in the middle ear through the TM defect after tilting the patients head towards the opposite ear.
- Within a week of evaluation of ETF, patients will be operated on for type 1 tympanoplasty after 3 weeks patients are reviewed for inspection of the operated ear. The second and third postoperative reviews will be done at 2 months and 6 months, respectively Patients were evaluated postoperatively by otoscopy, tympanometry, and audiometry.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Data were collected and analyzed using SPSS (Statistical Package for the Social Science, version 20, IBM, and Armonk, New York). Continuous data were expressed in form of mean ± SD while nominal data were expressed in form of frequency (percentage). Frequency tables and charts were used .
Chi²-test was used to compare the nominal data of different groups in the study. The level of confidence was kept at 95% hence a P value <0.05 indicated a significant association.
Description
Inclusion Criteria:
1-Patients diagnosed with tubotympanic type of CSOM during quiescent stage (dry perforation).
Exclusion Criteria:
- Active stage of tubotympanic CSOM (wet , discharging perforation).
- Patients with atticoantral type of CSOM.
- Patients with gross anatomical deformity or disease that can affect the result of tympanoplasty e.g cleft palate, severly deviated septum , adenoid, allergy , sinonasal polypi , otomycosis and presence of foci of infection.
- Patients with previous ear surgery .
- Patients with lost taste sensation .
- Patients with sensorineural hearing loss
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
saccharin test
The patients with SPT less than 20 minutes are considered to have a normally functioning ET. The patients with SPT between 20- 45 minutes are considered to have a partial dysfunction of ET . The patients with SPT more than 45 minutes are considered to have a gross dysfunction of the ET . |
Saccharin is a nonnutritive sweetener.
It has property of being inert to respiratory epithelium that is it does not hamper physiological mucus clearance of sino-nasal mucosa.
Methylene blue is a chemical compound.
It can be used to check patency of (ET).
The dye, because of its liquid form, gravitates through the ET to the nasopharynx.
Other Names:
|
methylene blue test
The patients with methylene blue clearance time less than 10 minutes are considered to have a normally functioning ET. The patients with methylene blue clearance time between10 to 20 minutes are considered to have a partial dysfunction of ET. The patients with methylene blue clearance time more than 20 minutes are considered to have a gross dysfunction of the ET . |
Saccharin is a nonnutritive sweetener.
It has property of being inert to respiratory epithelium that is it does not hamper physiological mucus clearance of sino-nasal mucosa.
Methylene blue is a chemical compound.
It can be used to check patency of (ET).
The dye, because of its liquid form, gravitates through the ET to the nasopharynx.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
out come of tympanoplasty
Time Frame: 2 years
|
Tympanoplasty was considered successful if graft healing was noticed together with a mean of postoperative air bone gap of 20 dB or less at frequencies of 500,1000, 2000,4000 dB.
|
2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DEmadtympanoplasty
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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