Tympanic Membrane Perforation
Conditions
Brief summary
Aim of this study is to compare results of double and single flap techniques for tympanoplasty in chronic suppurative otitis media patients. Inclusion criteria include total or subtotal tympanic membrane perforations with limited anterior remnant and should be dry for at least 3 months. Patients with persistent discharge, cholesteatoma, ossicular affection or those with recurrent perforations after previous myringoplasty were excluded. Also, patients with uncontrolled diabetes, chronic liver and kidney diseases and immuno-compromised patients are not included in this study. Patients are divided into two groups, endoscopic double flap group and endoscopic single flap group. Healing and hearing outcomes were evaluated 3 months postoperative. Also, post-operative pain scores and complications were assessed.
Interventions
PROCEDUREEndoscopic tympanoplasty
In the double flap group, graft is placed via elevation of both posterior and anterior flaps. In the single flap group, graft is placed via elevation of posterior flap only
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients with chronic suppurative otitis media with total or subtotal tympanic membrane perforation with limited anterior remnant. * dry perforation for at least 3 months.
Exclusion criteria
* Recurrent perforation after previous myringoplasty. * Ossicular disruption or fixation. * immune-compromised patients including uncontrolled diabetics, chronic liver and kidney diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing or graft take rate | 3 months after surgery | closure of tympanic membrane perforation |
Countries
Egypt
Outcome results
None listed