CompletedNot Applicable

Endoscopic Classic Versus Reversal Stapedotomy

Egypt60 participantsStarted 2021-09-01

Plain-language summary

Aim of The Work The aim of this study is to compare hearing outcome and surgical complications between classic and reversal endoscopic stapedotomy. Patients and Methods Study design: This study is a randomized clinical study and will be carried out at Otorhinolaryngology department at Mansoura University Hospitals. The study will be conducted among 60 patients with otosclerosis who will undergo endoscopic stapedotomy. The patients will be divided into two groups. The first group (group 1) 30 patients will undergo endoscopic classic stapedotomy while the second group (group 2) 30 patients will undergo endoscopic reversal stapedotomy. The two groups will compared to each other as regard, A. Intra-operative time (in minutes) B. Hearing outcome. C. Surgical complications

Who can participate

SexALL

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Inclusion Criteria: * Patients with history of gradual progressive hearing loss with normal otoscopy. * No history of ear discharge. * No history of ipsilateral ear surgery. * Air bone gap \>20 dB with lost stapedial reflex Exclusion Criteria: * Cases who did not meet the inclusion criteria. * Revision cases. * Cases that lost to follow up. * All cases with narrow oval window niche or obliterated footplate, because those are the contraindications of reversal technique as described by Fisch (Fisch et al., 1994).

What they're measuring

Average air conduction pure-tone threshold

Timeframe: 3 months

Word recognition score

Timeframe: 3 months

Average air bone gap

Timeframe: 3 months

Trial details

NCT IDNCT05554796

SponsorMansoura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-01

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