scholarly journals Effectiveness of endolymphatic duct blockage versus endolymphatic sac decompression in patients with intractable Ménière’s disease: study protocol for a double-blinded, randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e054514
Author(s):  
Annejet A Schenck ◽  
Josephina M Kruyt ◽  
Peter Paul van Benthem ◽  
Suzanne C Cannegieter ◽  
Wilbert B van den Hout ◽  
...  

IntroductionOutcomes 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.MethodsEighty-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 mature MD). All participants receive vestibular rehabilitation after surgery. Patients are followed up during 1 year after surgery. Follow-up visits will take place at 1 week, 3 months, 6 months and 12 months after surgery. The main study endpoint is proportion of patients who are free of vertigo spells at 12 months postoperatively. Secondary parameters include cumulative number of vertigo bouts, co-intervention, tinnitus, hearing, quality of life, cost effectiveness and a budget impact analysis. Total duration of the study is 4 years.AnalysisThe primary analysis will follow the intention-to-treat principle. For the primary outcome, a χ2 test will be performed. Secondary outcomes will be analysed using a linear mixed model (EDB versus decompression group) at the different time measurement point.Ethics and disseminationThis study was reviewed and approved by a board of specialists before funding was obtained, as well as by the Medical Research Ethics Committee Leiden-The Hague-Delft and the boards of all participating centres. Results of this study will be published in international peer-reviewed scientific journals and will be presented on (inter)national scientific conferences and meetings.Trial registration numbersNL9095 and ISRCTN12074571; Pre-Results.

2020 ◽  
Author(s):  
Wenqi Jiang ◽  
Junjiao Hu ◽  
Anquan Peng ◽  
Qin Wang ◽  
Xueying Pan ◽  
...  

Abstract To explore the differences between endolymphatic duct blockage (EDB) and endolymphatic sac drainage (EDD) surgery in the reversal of endolymphatic hydrops (EH) in patients with intractable Meniere’s disease (MD). A total of 19 MD patients receiving EDB (n=10) and EDD (n=9) treatment underwent gadoliniumenhanced inner ear magnetic resonance imaging (MRI) scans prior to, 2 weeks after and at >12 months following surgery. In the EDB group, the second MRI revealed no changes in EH, whereas the third MRI revealed a reversal of vestibular EH in 3 patients and a downgrading of cochlear hydrops in 2 of these 3 patients, who presented with an improvement in their hearing and complete control of vertigo. In the EDD group, the second MRI showed a reversal of EH in 4 patients, and no changes in EH in the remaining 5 patients, whereas the third MRI showed that those 4 patients who presented with a reversal of EH at the second MRI stage remained unchanged, with the exception of one patient who experienced a recurrence of vestibular hydrops. All 4 patients exhibited a complete control of vertigo, although hearing improved in only 1 of them, worsened in 1 and remained unchanged in 2. The present study showed the reversal in EH was likely due to the delayed effect of surgery accompanied by an improvement in hearing in EDB group, whereas the reduction in the endolymph volume presented as an acute reversal of hydrops in EDD group without a causeeffect relationship with hearing function.


Author(s):  
Anquan Peng ◽  
Junjiao Hu ◽  
Qin Wang ◽  
Xueying Pan ◽  
Zhiwen Zhang ◽  
...  

Abstract Background To explore the differences between endolymphatic duct blockage, endolymphatic sac drainage and endolymphatic sac decompression surgery in the reversal of endolymphatic hydrops (EH) in patients with intractable Meniere’s disease (MD). Methods A total of 27 MD patients receiving endolymphatic duct blockage surgery (n = 10), endolymphatic sac drainage surgery (n = 9) and endolymphatic sac decompression surgery (n = 8) underwent gadolinium-enhanced inner ear magnetic resonance imaging (MRI) scans prior to, 2 weeks after and at > 12 months following surgery. Results In the group with endolymphatic duct blockage, the second MRI revealed no changes in EH, whereas the third MRI revealed a reversal of vestibular EH in 3 patients and a downgrading of cochlear hydrops in 2 of these 3 patients, who presented with an improvement in their hearing and complete control of vertigo. In the group with endolymphatic sac drainage, the second MRI showed a reversal of EH in 4 patients, and no changes in EH in the remaining 5 patients, whereas the third MRI showed that those 4 patients who presented with a reversal of EH at the second MRI stage remained unchanged except a recurrence of vestibular hydrops in 1 patient. All 4 patients exhibited a complete control of vertigo, but hearing improved in 1, worsened in 1 and remained unchanged in 2. In the group with endolymphatic sac decompression, both the second and third MRI examination revealed no reversal of EH. Conclusions The present study has shown that both endolymphatic duct blockage surgery and endolymphatic sac drainage surgery have the potential to reduce EH in certain MD patients, but none of the patients receiving endolymphatic sac decompression surgery showed reversal of their EH. Graphical Abstract


1982 ◽  
Vol 90 (4) ◽  
pp. 470-481 ◽  
Author(s):  
Masaaki Kitahara ◽  
Taizo Takeda ◽  
Yoshiro Yazawa ◽  
Hideharu Matsubara ◽  
Hitoshi Kitano

Experimental hydrops caused by underabsorption of endolymphatic fluid is a model of remissional stage of Meniere's disease. In this study, another type of model, ie, hydrops caused by overproduction of endolymphatic fluid, was accomplished by applying various pressures into scala media through a micropipette via stria vascularis. This type of hydrops could be a model of attacks of Meniere's disease. By using two types of the model, effects of glycerol administration and of opening the endolymphatic sac were discussed.


1981 ◽  
Vol 90 (6) ◽  
pp. 619-623 ◽  
Author(s):  
Robert A. Jahrsdoerfer ◽  
Wayne S. Cail ◽  
Robert W. Cantrell

Herniation of the jugular bulb into the middle ear is uncommon. Extension of a jugular bulb diverticulum into the petrous pyramid is rare. In ten previously reported cases in the literature, only the radiographic appearance of the lesion was stressed. Of interest to otolaryngologists is the fact that in seven of the cases there was an ipsilateral sensorineural hearing loss. Other symptoms included tinnitus and vertigo. One patient had been diagnosed as having Menière's disease. We document an additional case (a patient who had “classical Menière's disease”) and report the first known surgical exploration of this venous anomaly. The diverticulum extended high into the petrous bone and was found to obliterate the distal segment of the endolymphatic duct. To our knowledge, this is the first time that a cause and effect relationship has been recognized between endolymphatic hydrops and a jugular bulb diverticulum. We propose that the diverticulum, by obstructing the endolymphatic duct, was directly responsible for the Menière's-like symptoms.


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