Effectiveness of endolymphatic duct blockage versus endolymphatic sac decompression in patients with intractable Meniere's disease: study protocol for a double-blinded, randomised controlled trial.

ABSTRACT:

Introduction

Outcomes of surgery for Ménière's disease (MD) remain discordant. Recently, a new surgical procedure in which the endolymphatic duct is clipped was proposed. To date, only one prospective trial assessing this technique was published, yielding promising results. This protocol describes a prospective, double-blinded, randomised controlled trial that will be carried out to assess the effectiveness of this surgical intervention.

Methods

Eighty-four patients with intractable MD will be recruited from 13 hospitals in the Netherlands. Intraoperatively, randomisation will determine whether endolymphatic duct blockage (EDB) or endolymphatic sac decompression (ESD) will be performed. Randomisation will be 1:1 stratified for gender and duration of MD (recent-onset versus m

SUBMITTER: Schenck AA 

PROVIDER: S-EPMC8356157 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature