Tympanoplasty Surgery
Conditions
Brief summary
Primary Objective: Compare 6-month graft success rates between 0.5 mm sliced and 1.8 mm full-thickness tragal cartilage grafts.(3) H1: Sliced cartilage yields ≥90% success versus ≤80% for full-thickness.(3) H0: No difference between arms. Secondary Objectives: * PTA-ABG closure at 6/12 months.(4) * Speech discrimination score improvement.(4) * Operative time.(6)
Detailed description
chronic suppurative otitis media with tympanic membrane perforation impacts a large number of adults worldwide, more in rural Upper Egypt due to recurrent infections.(1) These perforations cause ongoing ear discharge, hearing impairment, quality-of-life decline, and increased healthcare costs.(1) Conventional temporalis fascia grafting achieves 80-90% success in small defects but drops below 70% for subtotal/large perforations (\>50%tympanic membrane area) or with Eustachian tube issues.(2) Tragal cartilage grafting offers superior durability, with meta-analyses showing 92-98% closure rates versus 82-88% for fascia graft .(3) Full-thickness cartilage (\>1.5 mm), however, risks acoustic mass-loading, worsening high-frequency hearing by 8-12 dB at 4 kHz.(4) Partial-thickness slicing (0.4-0.6 mm) maintains strength while enhancing sound transmission, as shown in clinical series.(5) Endoscopic approaches further improve visualization and reduce operative trauma.(6) No randomized trials compare sliced versus full-thickness tragal cartilage in adult endoscopic tympanoplasty.(7,8) This pilot study fills that gap, optimizing technique for local needs before
Interventions
endoscopic type 1 tympano plasty
Sponsors
Study design
Eligibility
Inclusion criteria
* Age 18-65 years. * safe chronic perforation ≥6 months. * Subtotal (25-75%) or large (\>75%) pars tensa defect. * Dry ear ≥3 months (culture-negative). * Intact ossicles, healthy mucosa. * Viable tragal cartilage. * Informed written consent capability.
Exclusion criteria
* unsafe otitis, * active discharge, * Eustachian dysfunction e.g cleft palate, * ossicular defects * prior surgery, * unfit patients * non-compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outcome of partial-thickness vs full-thickness tragal cartilage grafts in endoscopic type 1 tympanoplasty in adults. | baseline | Outcome of partial-thickness vs full-thickness tragal cartilage grafts in endoscopic type 1 tympanoplasty in adults. |