Endolymphatic duct blockage is a relatively new treatment option for Ménière's disease, aiming to reduce vertigo attacks while sparing hearing and equilibrium. After a regular mastoidectomy, the... Show moreEndolymphatic duct blockage is a relatively new treatment option for Ménière's disease, aiming to reduce vertigo attacks while sparing hearing and equilibrium. After a regular mastoidectomy, the posterior semicircular canal is identified, and Donaldson's line is determined. This is a line through the horizontal semicircular canal, crossing the posterior semicircular canal. The endolymphatic sac is usually found at this site under the posterior semicircular canal. The bone of the endolymphatic sac and the dura are thinned until the sac is skeletonized, after which the endolymphatic duct is identified. The duct is then blocked with a titanium clip. Using a computerized tomography (CT) scan, the position is confirmed. Follow-up visits take place 1 week, 6 weeks and 1 year after surgery. To this day, only one prospective trial assessing this method has been conducted, comparing this new method to endolymphatic sac decompression. Results of the duct blockage are promising, with 96.5% of the patients free of vertigo after 2 years. However, further research is required. Show less
Esch, B. van; Zaag-loonen, H. van der; Bruintjes, T.; Benthem, P.P. van 2021
Background: Meniere's disease is characterized by recurrent episodes of vertigo, hearing loss, and tinnitus, often with a feeling of fullness in the ear. Although betahistine is thought to be... Show moreBackground: Meniere's disease is characterized by recurrent episodes of vertigo, hearing loss, and tinnitus, often with a feeling of fullness in the ear. Although betahistine is thought to be specifically effective for Meniere's disease, no evidence for a benefit from the use of betahistine exists, despite its widespread use. Reassessment of the effect of betahistine for Meniere's disease is now warranted. Search Methods: We searched for randomized controlled trials (RCTs) in the Central Register of Controlled Trials (CENTRAL), Ovid Medline, Ovid Embase, CINAHL, Web of Science, Clinicaltrials.gov, ICTRP, and additional sources for published and unpublished trials, in which betahistine was compared to placebo. Data Collection and Analysis: Our outcomes involved vertigo, significant adverse effect (upper gastrointestinal discomfort), hearing loss, tinnitus, aural fullness, other adverse effects, and disease-specific health-related quality of life. We used GRADE to assess the quality of the evidence. Main Results: We included 10 studies: 5 studies used a crossover design and the remaining 5 were parallel-group RCTs. One study with a low risk of bias found no significant difference between the betahistine groups and placebo with respect to vertigo after a long-term follow-up period. No significant difference in the incidence of upper gastrointestinal discomfort was found in 2 studies (low-certainty evidence). No differences in hearing loss, tinnitus, or well-being and disease-specific health-related quality of life were found (low- to very low-certainty of evidence). Data on aural fullness could not be extracted. No significant difference between the betahistine and the placebo groups (low-certainty evidence) could be demonstrated in the other adverse effect outcome with respect to dull headache. The pooled risk ratio for other adverse effect in the long term demonstrated a lower risk in favor of placebo over betahistine. Conclusions: High-quality studies evaluating the effect of betahistine on patients with Meniere's disease are lacking. However, one study with low risk of bias found no evidence of a difference in the effect of betahistine on the primary outcome, vertigo, in patients with Meniere's disease when compared to placebo. The main focus of future research should be on the use of comparable outcome measures by means of patient-reported outcome measures. Show less
Introduction Outcomes of surgery for Meniere's disease (MD) remain discordant. Recently, a new surgical procedure in which the endolymphatic duct is clipped was proposed. To date, only one... Show moreIntroduction Outcomes of surgery for Meniere'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 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.Analysis The primary analysis will follow the intention-to-treat principle. For the primary outcome, a chi(2) 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 dissemination This 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. Show less
Desuter, G.; Cartiaux, O.; Pierard, J.; Henrard, S.; Lith-Bijl, J. van; Benthem, P.P. van; Sjogren, E. 2020
Introduction. Accuracy of thyroid cartilage fenestration during Montgomery thyroplasty (MTIS) is considered a key success factor. The primary aim of the study was to retrospectively evaluate the... Show moreIntroduction. Accuracy of thyroid cartilage fenestration during Montgomery thyroplasty (MTIS) is considered a key success factor. The primary aim of the study was to retrospectively evaluate the accuracy of fenestration. Furthermore, recent publications indicate a possible discrepancy in MTIS voice outcomes related to gender. The secondary aim of the study was to investigate whether the fenestration accuracy could explain this discrepancy.Material and Method. Study was performed by virtually drawing the fenestration on a 3D CT scan as proposed by the MTIS's instructions for use (the "expected window" (EW)), and comparing it to the actually realized fenestration (the "realized window "(RW)). Four position variables, (a) surface overlap (%), (b) the distances between RW and EW centers (mm), (c) the angle between RW and EW (), and (d) the orientation of RW's center, were studied and compared to MPT (seconds) and VHI-30 scores outcomes. A descriptive statistical analysis and comparison between males and females were performed using a Mann-Whitney U test. Linear regression and multivariate analysis were also performed.Results. The median overlapping surface was 58.8 % [34.6; 75.4]. The median radius was 3.2 mm [1.7; 4.1]. The median angle was 16 [6.8; 21.2]. Results show no significant differences of overlapping surface percentage, distance, or angle by gender. Data show no correlation between voice outcome and percentage overlap, distance, or angle. However, data show better outcomes when fenestration was located in the infero-anterior orientation. All patients of this orientation were males.Conclusions. Data provided by this study advocate a maximal infero-anterior positioning of the window during MTIS. This position is more difficult to obtain in female patients. Show less
Introduction: Standardization of voice outcomes indicators (VOIs) is an important issue when it comes to evaluating and comparing surgical treatments for Unilateral Vocal Fold Paralysis (UVFP). In... Show moreIntroduction: Standardization of voice outcomes indicators (VOIs) is an important issue when it comes to evaluating and comparing surgical treatments for Unilateral Vocal Fold Paralysis (UVFP). In a recent review, 11 VOIs were found to represent 80% of the VOIs cited in the literature. A survey was launched among the European laryngologists to acquire surgeons' opinions on the above mentioned preselected VOIs.Material and method: The electronic survey took place between November and December 2016. Three general questions were asked about surgeon's practice setting(s) and experience. The eleven next questions concerned (a) surgeon's VOIs preference and (b) their estimates of post-operative target values, they would consider being satisfactory.Results: The response rate was 16% (50 surveys). The majority of responders worked in tertiary hospitals (50%), had 15 years of experience with UVFP and performed on average 20 UVFP related procedures a year. The VOIs that were favored by the responding surgeons were, in decreasing order of importance, Voice handicap Index (VHI-30), Maximum Phonation Time (MPT), GRBAS-I, Mean Airflow Rate (MeAF), Jitter and Shimmer. There was an excellent consensus on post-operative VOI target values between survey's results and the literature data, except for three VOIs that showed somewhat divergent tendencies (absolute VHI-30, Jitter and Shimmer).Conclusions: Three VOIs are favored by surgeons: VHI-30, MPT and GRBAS-I. Jitter and Shimmer, although very frequently reported and statistically valid in the literature, come last concerning surgeon's choice as VOI for UVFP treatment assessment. (C) 2019 Elsevier Masson SAS. All rights reserved. Show less
Desuter, G.; Cartiaux, O.; Pierard, J.; Henrard, S.; Lith-Bijl, J. van; Benthem, P.P. van; Sjogren, E. 2019
Introduction Accuracy of thyroid cartilage fenestration during Montgomery Thyroplasty (MTIS) is considered a key success factor. The primary aim of the study was to retrospectively evaluate the... Show moreIntroduction Accuracy of thyroid cartilage fenestration during Montgomery Thyroplasty (MTIS) is considered a key success factor. The primary aim of the study was to retrospectively evaluate the accuracy of fenestration. Furthermore, recent publications indicate a possible discrepancy in MTIS voice outcomes related to gender. The secondary aim of the study was to investigate whether the fenestration accuracy could explain this discrepancy. Material and Method Study was performed by virtually drawing the fenestration on a 3D CT-scan as proposed by the MTIS’s instructions for use (the “expected window” (EW)), and comparing it to the actually realized fenestration (the “realized window "(RW)). Four position variables, (a) surface overlap (%), (b) the distances between RW and EW centers (mm), (c) the angle between RW and EW and (d) the orientation of RW’s center, were studied and compared to MPT (Sec) and VHI-30 scores outcomes. A descriptive statistical analysis and comparison between males and females were performed using a Mann-Whitney U test. Linear regression and multivariate analysis were also performed. Results The median overlapping surface was 58.8 % [34.6; 75.4]. The median Radius was 3.2 mm [1.7; 4.1]. The median angle was 16° [6.8; 21.2]. Results show no significant differences of overlapping surface percentage, distance or angle by gender. Data show no correlation between voice outcome and percentage overlap, distance or angle. However, data show better outcomes when fenestration was located in the infero-anterior orientation. All patients of this orientation were males. Conclusions Data provided by this study advocate a maximal infero-anterior positioning of the window during MTIS. This position is more difficult to obtain in female patients. Show less
Desuter, G.; Zapater, E.; Vorst, S. van der; Henrard, S.; Lith-Bijl, J.T. van; Benthem, P.P. van; Sjogren, E.V. 2018
Objective: The aim of this multicentric cross-sectional study was to examine the permanency of Montgomery thyroplasty (MTIS) results from a patient's perspective.Design: The study consisted of... Show moreObjective: The aim of this multicentric cross-sectional study was to examine the permanency of Montgomery thyroplasty (MTIS) results from a patient's perspective.Design: The study consisted of collecting Voice Handicap Index (VHI-30) questionnaires from patients who had previously been operated with MTIS between 2 and 12years before. Very long-term (>2years) postoperative data were compared with the previously acquired preoperative and early postoperative VHI results. Influence of factors such as age, gender, size/side of the prosthesis and length of the follow-up were also analysed.Setting: Multicentric study involving three tertiary European voice centres.Participants: Forty-nine unilateral vocal fold paralysis (UVFP) patients, treated by MTIS, were included in the study.Main outcome measures: The Voice Handicap Index-30 score.Results & Conclusions: The median VHI was significantly different over time-points (Friedman's test P<.001), with a significant difference between preoperative and early postoperative time-points (median VHI: 70 vs 21, respectively; P<.001) and between preoperative and very long-term postoperative time-points (median VHI: 70 vs 16, respectively; P<.001). The median VHI did not differ for the early and very long-term postoperative time-points (median VHI: 21 vs 16; P=.470).Age differences, gender differences and size/side differences of the prostheses, centres where surgery took place and length of the follow-up showed no significant influence.Medialisation thyroplasty (MT) overall and MTIS, in particular, should be considered as a possible standard of care for UVFP when permanency of voice results is sought. Show less
Desuter, G.; Dedry, M.; Schaar, B.; Lith-Bijl, J. van; Benthem, P.P. van; Sjogren, E.V. 2018
There is no consensus on which voice outcome indicators (VOIs) should be used to compare the merits of the various surgical treatments for unilateral vocal fold paralysis (UVFP). Authors performed... Show moreThere is no consensus on which voice outcome indicators (VOIs) should be used to compare the merits of the various surgical treatments for unilateral vocal fold paralysis (UVFP). Authors performed a literature review to identify which VOIs are most frequently used and most relevant, in terms of significant change in pre- and post-operative measurements, to assess UVFP surgical treatments.A Medline/Pubmed literature review was performed and the most frequently used VOIs were identified using a Pareto diagram. For these most frequently used VOI's, the number of studies that showed a statistically significant change in pre- and post-operative results were compared to the total number of studies found using that same VOI, this portion was expressed in percent. This percentage was defined as the "percentage of significance" and used to assess changes of each VOI.Eleven VOIs were identified using the Pareto analysis. These were, in decreasing order of frequency of citation: maximum phonation time (MPT), jitter, Shimmer, video-stroboscopic examination, noise to harmonic ratio (NHR/HNR), mean air flow (MeAF), fundamental frequency (F0), "Infrequent Perceptional Scales", GRBAS scale, mean subglottic pressure (MSGP). MPT, MeAF, factor G of GRBAS-I, Jitter, shimmer and VHI-30 had respective "percentage of significance" of 90, 86, 85, 74, 68 and 64%, respectively.The results indicate that MPT, MeAF and GRBAS-I, represent the top-three most frequently used and the most relevant VOIs in terms of "percentage of significance". VHI-30 showed a relatively low rate of use and low "percentage of significance". The role of Jitter and Shimmer remains unclear. Finally, MSGP and the F0 appear to be less relevant VOIs for the evaluation of UFVP surgical treatments in terms of significant change in pre- and post-operative measurements. Show less
Desuter, G.; Mertens, B.; Delchambre, A.; Lith-Bijl, J. van; Benthem, P.P. van; Sjogren, E. 2017
Introduction: Many concerns have been expressed in the past about the assessment of vocal fold positions as part of (a) pre-operative planning and (b) post-operative outcome for larynx framework... Show moreIntroduction: Many concerns have been expressed in the past about the assessment of vocal fold positions as part of (a) pre-operative planning and (b) post-operative outcome for larynx framework surgery. Presently there is no clear strategy allowing, harmed free and office-based assessment of vocal fold vertical relative positions. The Larynx Ruler (LR) is a laser based, measuring device that could meet the previously stated need. This study represents a proof of concept regarding the use of LR in assessing vocal fold height and profile. Material and methods: One fresh male human cadaver larynx was explored with the LR system through the operative channel of a gastroenterology video-endoscope. The tip of the video-endoscope was located in the laryngeal vestibule. The right crico-arytenoid joint was posteriorly disarticulated allowing anterior and posterior tilting of the arytenoid cartilage, this to create an elevation or a depression of the vocal process. Ten push-pull motions sessions were applied to the specimen. These experimentally induced motions were compared with measurements provided by the LR Results: Data provided by the LR were always in accordance with movements applied on the vocal folds. The accuracy of 0.2 mm of the LR is compatible with the envisioned applications for the larynx. Conclusions: The LR system represented a feasible technique to evaluate vocal fold’s heights and bulk in humans. A few technical limitations were identified that will require improvements before experimental use on human. Show less
Desuter, G.; Dedry, M.; Schaar, B.; Lith-Bijl, J. van; Benthem, P.P. van; Sjogren, E.V. 2017
Introduction There is no consensus on which voice outcome indicators (VOI) should be used to compare the merits of the various surgical treatments for unilateral vocal fold paralysis (UVFP).... Show moreIntroduction There is no consensus on which voice outcome indicators (VOI) should be used to compare the merits of the various surgical treatments for unilateral vocal fold paralysis (UVFP). Authors performed a literature review to identify which VOIs are most frequently used and most relevant, in terms of significant change in pre- and post-operative measurements, in order to assess UVFP surgical treatments. Method A Medline/Pubmed literature review was performed and the most frequently used VOIs were identified using a Pareto diagram. For these most frequently used VOI’s the number of studies that showed a statistically significant change in pre and post-operative results were compared to the total number of studies found, this portion was expressed in percent. This percentage was defined as the “percentage of significance” and used to assess changes of each VOI. Results Eleven VOIs were identified using the Pareto analysis. These were, in decreasing order of frequency of citation: Maximum Phonation Time (MPT), Jitter, Shimmer, Video-stroboscopic examination, Noise to Harmonic Ratio (NHR/HNR), Mean Air Flow (MeAF), Fundamental Frequency (F0), “Infrequent Perceptional Scales”, GRBAS scale, Mean Subglottic Pressure (MSGP). MPT, MeAF, factor G of GRBAS-I, Jitter, shimmer and VHI-30 had respective “percentage of significance” of 90%, 86%,85%,74%, 68% and 64% respectively. Conclusion The results indicate that MPT, MeAF and GRBAS-I, represent the top-three most frequently used and the most relevant VOIs in terms of “percentage of significance”. VHI showed a relatively low rate of use and low “percentage of significance”. The role of Jitter and Shimmer remains unclear. Finally, MSGP and the F0 appear to be less relevant VOIs for the evaluation of UFVP surgical treatments in terms of significant change in pre- and post-operative measurements. Show less
Sonsbeek, S. van; Pullens, B.; Benthem, P.P. van 2015
