NCT07471191

Partial Thickness vs Full Thickness Tragal Cartilage Grafts in Endoscopic Type 1 Tympanoplasty

Outcome of Partial-thickness vs Full-thickness Tragal Cartilage Grafts in Endoscopic Type 1 Tympanoplasty in Adults.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tympanoplasty Surgery

Interventions

Type	Name	Description
DEVICE	endoscope	endoscopic type 1 tympano plasty

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-04-01
• Completion: 2028-05-01
• First posted: 2026-03-13
• Last updated: 2026-03-13