endoscope
Deviceendoscopic type 1 tympano plasty
Other names: tympanoplasty
NCT Number: NCT07471191
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)
Trial opening soon.
Get Notified18 year–65 year
All sexes
Observational
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
endoscopic type 1 tympano plasty
Other names: tympanoplasty
Time frame: baseline
Outcome of partial-thickness vs full-thickness tragal cartilage grafts in endoscopic type 1 tympanoplasty in adults.
Contact information is provided by the study sponsor or research team.
Ezzat Mohamed Saleh, Prof
CONTACT
Monica Gamil Tawfiq
CONTACT
Assiut University
Other
Outcome of Partial-thickness vs Full-thickness Tragal Cartilage Grafts in Endoscopic Type 1 Tympanoplasty in Adults.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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NCT07084636
Laryngeal Mask Airway, Tympanoplasty Surgery
Samsun, Ilkadım, Turkey (Türkiye)
View Trial Details