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A Comparison of Endoscopic Transtympanic Myringoplasty and Endoscopic Type I Tympanoplasty for Repairing Medium- to Large-Sized Tympanic Membrane Perforation: A Randomized Clinical Trial

Comparison of endoscopic transtympanic myringoplasty and endoscopic tympanoplasty type I in repairing medium to large sized tympanic perforations

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200227001
Enrollment
Unknown
Registered
2020-02-27
Start date
2018-02-19
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Tympanic membrane perforation endoscopy tympanoplasty transtympanic myringoplasty tympanic membrane perforation

Interventions

The ETM group had the graft placed through the perforation (without tympanomeatal flap elevation),the ETT group had the graft placed via elevation of the tympanomeatal flap
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
endoscopic transtympanic myringoplasty (ETM) ,endoscopic type I tympanoplasty (ETT)

Sponsors

Faculty of Medicine, Prince of Songkla University
Lead Sponsor
Human Research Ethics Committee Faculty of Medicine
Collaborator

Eligibility

Sex/Gender
All
Age
16 Years to 70 Years

Inclusion criteria

Inclusion criteria: medium- to large-sized central perforation dry middle ear for the last 3 months

Exclusion criteria

Exclusion criteria: previous ear operations cholesteatoma ossicular chain disease suggested by pure tone audiometry (ABG of more than 30 dB) middle ear mucosal edema with persistent aural discharge craniofacial abnormalities an ear canal that was too narrow to accommodate the endoscope (ear canal diameter of less than 3 mm)

Design outcomes

Primary

MeasureTime frame
Graft take rate at 6 months after end of the intervention (surgery) Endoscopic examination,Operative time ,operative time the duration from the beginning of local anesthetic injection to the completion of the wound dressin time record—

Secondary

MeasureTime frame
Operative time the duration from the beginning of local anesthetic injection to the completion of the wound dressin time record,Pain score 4, 24 and 48 hours after end of the intervention (surgery) Visaul Analog Scale,Hearing improvement 2 months after end of the intervention (surgery) audiometry—

Countries

Thailand

Contacts

Public ContactViraporn Atchariyasathian

Department of Otolaryngology Faculty of Medicine, Prince of Songkla University

viraporm.a@psu.ac.th66897387758

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026