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Outcomes of Endoscopic Type I Cartilage Tympanoplasty With and Without Meatal Flap Elevation

A prospective, two-arm, parallel-group randomized controlled trial of endoscopic type I cartilage tympanoplasty with versus without tympanomeatal flap elevation in adults with inactive tubotympanic chronic suppurative otitis media

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202607746154860
Enrollment
50
Registered
2026-07-06
Start date
2024-12-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ear, Nose and Throat

Interventions

Endoscopic type I cartilage tympanoplasty WITH tympanomeatal flap elevation
Endoscopic type I cartilage tympanoplasty WITHOUT flap elevation

Sponsors

Minia University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adults aged 18 years or older Inactive tubotympanic chronic suppurative otitis media (CSOM) Dry central tympanic membrane perforation for at least 3 months Conductive hearing loss with no sensorineural component (normal bone conduction) Intact, mobile ossicular chain Normal middle-ear mucosa on otoscopic/endoscopic examination

Exclusion criteria

Exclusion criteria: Unfit for general anaesthesia Cervical-spine disorders limiting operative positioning Active otorrhoea, granulation tissue or mucosal inflammation Atticoantral disease or cholesteatoma Traumatic perforation Previous (revision) ear surgery on the affected ear Otitis externa Sensorineural hearing loss Refusal to participate

Design outcomes

Primary

MeasureTime frame
Graft uptake/success (complete vs partial vs failed/re-perforated), assessed by endoscopic otoscopy;Hearing improvement — air–bone gap (ABG) closure to =20 dB or a reduction of =10 dB from baseline, by pure-tone audiometry

Secondary

MeasureTime frame
Early postoperative pain on the Visual Analogue Scale (VAS, 0–10)

Countries

Egypt

Contacts

Public ContactMohamed Shaban

Resident

mohamed.shabanmedical@gmail.com+201156308414

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026