Search

Background: To improve the understanding of the thermodynamics and performance of small passive hygroscopic Heat and Moisture Exchangers (HMEs), a computer model simulating HME function is required. Methods: We developed a numerical HME model to calculate the HME's water and heat exchange. The model was tuned and verified with experimental data and validated by applying it to HME design variations. Results: Verification of the model's results to the experimental data shows that the tuned model yields reliable results. The mass of the core, which determines the HME's total heat capacity, is the most important parameter influencing the performance of passive HMEs. Conclusions: Increasing the HME's diameter is an effective way to improve an HME, as it yields higher performance and lowers breathing resistance. HMEs intended for use in warm or dry climates should contain more and those for use in cold humid climates should contain less hygroscopic salt.

Objective Voice prosthesis leakage significantly affects the quality of life of patients undergoing laryngectomy, causing insecurity and frequent unplanned hospital visits and costs. In this study, the concept of prophylactic voice prosthesis replacement was explored to prevent leakages. Study Design Retrospective cohort study. Setting Tertiary hospital. Methods This study included all patients who underwent laryngectomy between 2000 and 2012 in the Netherlands Cancer Institute. Device lifetimes and voice prosthesis replacements of a retrospective cohort were used to calculate the number of needed voice prostheses per patient per year to prevent 70% of the leakages by prophylactic replacement. Various strategies for the timing of prophylactic replacement were considered: adaptive strategies based on the individual patient's history of replacement and fixed strategies based on the results of patients with similar voice prosthesis or treatment characteristics. Results Patients used a median 3.4 voice prostheses per year (range, 0.1-48.1). We found high inter- and intrapatient variability in device lifetime. When prophylactic replacement is applied, this would become a median 9.4 voice prostheses per year, which means replacement every 38 days, implying >6 additional voice prostheses per patient per year. The individual adaptive model showed that preventing 70% of the leakages was impossible for most patients and only a median 25% can be prevented. Monte-Carlo simulations showed that prophylactic replacement is not feasible due to the high coefficient of variation (SD/mean) in device lifetime. Conclusion Based on our simulations, prophylactic replacement of voice prostheses is not feasible due to high inter- and intrapatient variation in device lifetime.

Wound healing is a complex biological process subject to complications that might jeopardize the patient's postoperative care. Appropriately approaching surgical wounds after head and neck surgery positively influences the quality and speed of wound healing and increases patient comfort. A large variety of dressing materials currently exist that allow the care of different types of wounds. Nevertheless, there is limited literature on the most suitable types of dressings after head and neck surgery. The objective of the present article is to review the most commonly used wound dressings, their benefits, indications, and disadvantages, and to provide a systematic approach for wound care within the head and neck. The Woundcare Consultant Society distinguishes wounds into three groups: black, yellow, and red. Each type of wound represents distinctive underlying pathophysiological processes with unique needs. Utilizing this classification along with the TIME model allows a proper characterization of wounds and the identification of potential healing barriers. This evidence-based and systematic approach can facilitate and guide the head and neck surgeon in selecting a wound dressing upon acknowledging their properties, which are herein reviewed and exemplified with representative cases.

Objective: This study aims to assess the product performance of a new moldable peristomal adhesive with corresponding heating pad designed to facilitate and improve automatic speaking valve (ASV) fixation for hands-free speech in laryngectomized patients. Methods: Twenty laryngectomized patients, all regular adhesive users with prior ASV experience, were included. Study-specific questionnaires were used for data collection at baseline and after two weeks of moldable adhesive use. The primary outcome parameters were adhesive lifetime during hands-free speech, use and duration of hands-free speech, and patient preference. Additional outcome parameters were satisfaction, comfort, fit, and usability. Results: The moldable adhesive enabled ASV fixation adequate for hands-free speech in the majority of participants. Overall, the moldable adhesive significantly increased adhesive lifetime and duration of hands-free speech compared to participants' baseline adhesives (p < 0.05), regardless of stoma depth, skin irritation, or regular use of hands-free speech at baseline. The participants who preferred the moldable adhesive (55% of participants) experienced a significant increase in the adhesive lifetime (median of 24 h, range 8–144 h) and improved comfort, fit, and ease of speech. Conclusion: The moldable adhesive's lifetime and functional aspects, including the ease of use and custom fit, are encouraging outcomes and enable more laryngectomized patients to use hands-free speech more regularly. Level of Evidence: 4 Laryngoscope, 2023.

Purpose The purpose of this study is to assess the general course of acoustic, patient rated, and clinician-rated voice outcomes from pre- up to 12 months post total laryngectomy. Methods Patients admitted to a total laryngectomy in five participating hospitals in Australia and The Netherlands were included. Assessments took place at pre-, 3 months, 6 months, and 12 months post-surgery. Voice outcomes are evaluated with the Acoustic Voice Quality Index (AVQI), perceptual scales, and patient-reported outcome measures including VHI-10 and EQ-5D-5L. Statistical analyses include descriptive statistics, t tests (pre- to 6 months post-surgery), Linear Mixed Effect models. Results The study included 43 participants. A significant worsening of AVQI is seen from pre- to post-surgery evaluated with t test (p Time as a significant factor in predicting AVQI score (p ≤ 0.001), as well as perceptual rated voice quality by the clinician (p = 0.015) and patient-reported perceptual rated voice quality (p = 0.002). No statistical significance was found in VHI-10 scores over time. Conclusion Successful TE-speech was achieved in most participants, some had to rely on augmentative alternative communication methods. Patient-reported outcomes indicate acceptance of the condition and sufficient coping in the long term. However, acoustic rated voice quality is abnormal at all post-surgery time-points. AVQI proved to be a useful instrument to evaluate TE-speech. There is a need for validation and determination of cut-off values for VHI-10 and AVQI for use in TE-speech.

Background: Due to the heat and moisture exchanger's (HME) breathing resistance, laryngectomized patients cannot always use an (optimal) HME during physical exercise. We propose a novel HME cassette concept with adjustable “bypass,” to provide adjustment between different breathing resistances within one device. Methods: Under standardized conditions, the resistance and humidification performance of a high resistance/high humidification HME (XM) foam in a cassette with and without bypass were compared to a lower resistance/lesser humidification HME (XF) foam in a closed cassette. Results: With a bypass in the cassette, the resistance and humidification performance of XM foam were similar to those of XF foam in the closed cassette. Compared to XM foam in the closed cassette, introducing the bypass resulted in a 40% resistance decrease, whereas humidification performance was maintained at 80% of the original value. Conclusions: This HME cassette prototype allows adjustment between substantially different resistances while maintaining appropriate humidification performances.

Permanent hands-free speech with the use of an automatic speaking valve (ASV) is regarded as the optimal voice rehabilitation after total laryngectomy. Due to fixation problems, regular ASV use in patients with a laryngectomy is limited. We have developed an intratracheal fixation device (ITFD) composed of an intratracheal button augmented by hydrophilic foam around its shaft. This study evaluates the short-term effectiveness and experienced comfort of this ITFD during hands-free speech in 7 participants with a laryngectomy. We found that 4 of 7 participants had secure ASV fixation inside the tracheostoma during hands-free speech for at least 30 minutes with the ITFD. The ITFD’s comfort was perceived positively overall. The insertion was perceived as being mildly uncomfortable but not painful. This proof-of-concept study demonstrates the feasibility of the ITFD that might improve stomal attachment of ASVs, and it provides the basis for further development toward a prototype suitable for long-term daily use.

Permanent hands-free speech with the use of an automatic speaking valve (ASV) is regarded as the optimal voice rehabilitation after total laryngectomy. Due to fixation problems, regular ASV use in laryngectomized patients is limited. We have developed a novel intratracheal fixation device (ITFD), composed of an intratracheal button augmented by a hydrophilic PVA foam exterior around its shaft. The aim of this study was to evaluate the ITFD’s feasibility in vitro, defined as an effective ASV fixation without causing mucosal tissue traumatization. We found that when the expanded PVA foam is compressed less than 60% of its original thickness, it can potentially provide both a safe and effective ASV fixation in a range of tracheostoma morphologies; enough fixation to withstand pressures related to loud speech (approximately 6 kPa) without exerting excessive pressure (>32 mmHg) which could lead to ischemic damage to the tracheal tissue. This study demonstrates the feasibility of the ITFD in vitro that might improve stomal attachment of ASVs. The ITFD’s deformable foam exterior may provide an effective fixation in most laryngectomized patients, compared to commercially available fixation methods, without the need for a user-specific customization. The results of a clinical feasibility study in laryngectomized patients are pending.

The American Joint Committee on Cancer (AJCC) uses the same nodal staging system for cutaneous and mucosal squamous cell carcinoma of the head and neck in its 8th edition (AJCC 8) despite differences in the etiology, risk factors, and clinical behavior of the two diseases. This study aims to evaluate the performance of the AJCC 8 nodal staging system by direct comparison of cutaneous (cSCC) versus oral squamous cell carcinoma (oSCC) patients. Patients with metastatic cSCC (N = 382) and oSCC (N = 325) were identified from a prospective database (years 1987–2016). Multivariable analysis was performed using Cox proportional hazards competing risk model. To assess staging system performance, an explained variation measure (proportion of variation explained, PVE) as well as a discrimination measure (Harrell’s concordance index, C-index) were used. Inclusion of extranodal extension (ENE) in AJCC 8 increased the proportion of patients in N3b category (48.7% in cSCC, 40.3% in oSCC). AJCC 8 stratified poorly with regards to risk of death from cSCC and oSCC and showed limited monotonicity of the nodal categories. Estimates of model performance revealed modest predictive capacity for overall survival (OS) and disease-specific survival (DSS) in oSCC (Harrell’s C of 0.66 in both) and weak predictive capacity in cSCC (Harrell’s C of 0.58 and 0.61, respectively). The AJCC 8 nodal staging system performs poorly in terms of stratifying survival by N category, especially in cSCC. The data indicate that cSCC merits an independent nodal staging system from that for mucosal SCC.

Objectives The primary aim of this study is to compare the effect of using tumor thickness versus depth of invasion (DOI) to determine the 8th edition AJCC T-category on survival in a large cohort of OSCC. Materials and methods A retrospective cohort study of patients whose clinicopathologic information had been collected prospectively into a dedicated head and neck database. 927 patients with oral SCC were identified in this cohort, with the final study population including 456 patients with complete information on DOI, tumor thickness, T and N staging and follow-up. Results 26 (5.7%) patients had a different AJCC 8 T category when using thickness instead of depth. 15 were upstaged from T1 to T2, 10 upstaged from T2 to T3 and 1 down staged from T2 to T1. Additionally, similar stratification of disease-specific and overall survival curves were found for T category based on DOI and thickness. Conclusion The T category and TNM stage prognostic performance of 8th edition AJCC staging of oral cancer is similar regardless of whether DOI or thickness is used as the T-category modifier. In centers without complete DOI data it is reasonable to impute thickness for retrospective survival analyses using the 8th edition of the AJCC staging system.

Background The majority of patients with head and neck squamous cell carcinoma (HNSCC) receive bilateral elective nodal irradiation (ENI), in order to reduce the risk of regional failure. Bilateral ENI, as compared to unilateral ENI, is associated with higher incidence of acute and late radiation-induced toxicity with subsequent deterioration of quality of life. Increasing evidence that the incidence of contralateral regional failure (cRF) in lateralized HNSCC is very low ( Methods In this one-armed, single-center prospective trial, patients with primary T1-4 N0-2b HNSCC of the oral cavity, oropharynx, larynx (except T1 glottic) or hypopharynx, not extending beyond the midline and planned for primary (chemo) radiotherapy, are eligible. After 99mTc-nanocolloid tracer injection in and around the tumor, lymphatic drainage is visualized using SPECT/CT. In case of contralateral lymph drainage, a contralateral sentinel node procedure is performed on the same day. Patients without contralateral lymph drainage, and patients with contralateral drainage but without pathologic involvement of any removed contralateral sentinel nodes, receive unilateral ENI. Only when tumor cells are found in a contralateral sentinel node the patient will be treated with bilateral ENI. The primary endpoint is cumulative incidence of cRF at 1 and 2 years after treatment. Secondary endpoints are radiation-related toxicity and quality of life. The removed lymph nodes will be studied to determine the prevalence of occult metastatic disease in contralateral sentinel nodes. Discussion This single-center prospective trial aims to reduce the incidence and duration of radiation-related toxicities and improve quality of life of HNSCC patients, by using lymph drainage mapping by SPECT/CT to select patients with a minimal risk of contralateral nodal failure for unilateral elective nodal irradiation. Trial registration ClinicalTrials.gov Identifier: NCT03968679, date of registration: May 30, 2019.

Background Neopharyngeal stenosis is a recognized sequela of total laryngectomy (TL). We aim to investigate the incidence of stenosis requiring dilation, risk factors for stenosis and complications of dilation. Methods Retrospective cohort study of patients undergoing TL in two dedicated head and neck centers in the Netherlands. Results A total of 477 patients, (81% men, median age of 64 at TL) were included. Indication for TL was previously untreated primary tumor in 41%, salvage following (chemo)radiotherapy (CRT) in 44%, dysfunctional larynx in 9% and a second primary tumor in 6%. The cumulative incidence of dilatation at 5 years was 22.8%, and in total 968 dilatations were performed. Median number of dilations per patient was 3 (range 1–113). Female gender, a hypopharynx tumor, and (C)RT before or after the TL were significantly associated with stenosis requiring dilation. We observed 8 major complications (0.8%) predominantly during the first dilation procedures. Use of general anesthesia is a risk factor for complications. The most frequent major complication was severe esophageal perforation (n = 6 in 5 patients). Conclusion The cumulative incidence of pharyngeal stenosis needing dilation was 22.8% at 5 years. Roughly half of these patients could be treated with a limited number of dilations, the rest however needed ongoing dilations. Major complications are rare (0.8%) but can be life threatening. General anesthetics is a risk factor for complications, and complications occurred predominantly during the first few dilations procedures. This should alert the physician to be extra careful in new patients.

Regional nodal metastases from cutaneous squamous cell carcinoma (cSCC) is strongly associated with a poor prognosis, but these metastases are difficult to predict clinically. Sentinel node biopsy (SNB) has been used for a wide range of malignancies to assess for regional nodal metastasis, but is not widely used for cSCC. Patients presenting with high-risk cSCC of the head and neck with clinically N0 necks were offered SNB at the time of primary cSCC excision or secondary wide local excision. Patients with positive sentinel nodes were offered completion lymph node dissection, and all the patients were followed up at regular intervals for up to 5 years. In this study, 105 lesions underwent SNB, and 10 sentinel nodes (9.5%) were positive. In an additional five patients, regional recurrence developed after a negative sentinel node, with a total subclinical nodal metastasis rate of 14.3%. Nodal metastases were significantly associated with reduced disease-specific survival. The significant predictors of metastasis were four or more high-risk features or tumors with a concurrent invasion deeper than 5 mm and PNI. For high-risk cSCC, SNB is a safe and feasible staging technique. The total number of high risk features and certain combinations of high-risk features predicted metastasis better than individual high-risk features.

Kanker in het hoofd-halsgebied staat op dit moment in de top 10 van meest voorkomende maligniteiten in Nederland. Het aantal hoofd-halstumoren neemt jaarlijks toe en ook jongere mensen lopen steeds meer risico.

OBJECTIVES/HYPOTHESIS: The majority of laryngectomy patients fail to use a hands-free valve on a daily basis, mainly due to fixation problems of the adhesive baseplate housing. To support adhesive housings during hands-free speech a new external neck brace (ENB 2.0) was developed. The effect of the brace was assessed in terms of a qualitative assessment, adhesive lifetime, maximum phonation time and patient self-reports. STUDY DESIGN: Twenty laryngectomees participated in this randomized, prospective, crossover trial. METHODS: All participants used the Provox hands-free HME valve with an Xtrabase adhesive for 1 month, 2 weeks with an ENB 2.0, and 2 weeks without. Outcomes were compared with the previous model of the external neck brace (ENB 1.0). RESULTS: The average total number of adhesive baseplates used during the trial was 16.7 in the non-brace group versus 10.9 in the brace group (P = 0.05). The number of daily replacements was 1.4 in the non-brace group and 1.1 in the brace group (P = 0.025). The average time a hands-free valve was worn per baseplate was 9.5 hours when wearing a neck brace versus 7.3 hours without brace (P = 0.09).The majority (81%) of the patients considered the neck brace 2.0 as a welcome addition to improve hands-free speech after laryngectomy and would use it if prescribed (88%). CONCLUSION: The new model of the neck brace reduces the number of baseplate replacements during hands-free speech and is considered as a helpful device by 81% of the participants. LEVEL OF EVIDENCE: 1b. Laryngoscope, 123:2209-2215, 2013.

Item does not contain fulltext OBJECTIVES/HYPOTHESIS: Time of adherence of adhesive baseplate housings to the neck of a laryngectomized patient is one of the main problems that account for the low number of laryngectomy patients who benefit from hands-free speech. An external neck brace (ENB 1.0) was introduced to support peristomal fixation of adhesive baseplates. STUDY DESIGN: A prospective randomized controlled clinical cross-over trial. METHODS: A total of 28 laryngectomy patients participated in this randomized, prospective, crossover trial. All used the Provox hands-free heat and moisture exchanger (HME) valve for 1 month: 2 weeks with an ENB and 2 weeks without. RESULTS: The median lifetime of an adhesive baseplate without a brace was 52.5 minutes versus 210 minutes with a brace (P = .03). Four participants considered the ENB as "a little" bit of a welcome addition, nine as "quite a bit," and six as "very much" (79%) to improve hands-free speech. CONCLUSIONS: The ENB significantly increases the lifetime of an adhesive baseplate and therefore contributes to achieving hands-free speech for a greater number of patients with laryngectomy. 01 juni 2012

OBJECTIVES: This study evaluates the relation between stoma volumes by means of objective three-dimensional measurements of laryngectomised individuals and peristomal fixation of adhesive baseplates during hands-free speech. DESIGN: A three-dimensional stereophotogrammetrical image was captured of the tracheostoma and its surrounding tissue for each participant. The placement of a baseplate adhesive was virtually simulated. Individual stoma volumes were calculated and related to the duration of lifetime of adhesive baseplates. SETTING: Prospective trial in a university hospital setting. PARTICIPANTS: Twenty-four laryngectomised patients. MAIN OUTCOME MEASURES: Stoma volume in cm(3) and adhesive baseplate adherence in minutes. RESULTS: For the 24 three-dimensional images captured, the mean volume of the area under the adhesive (stoma volume) was 9.5 cm(3) (range 3.5-22.5). After relating the different volumes of all patients to their individual fixation score, a significant decrease in duration of adhesive lifetime was found with increasing volumes of the stoma (P = 0.001). An increase of 1 cm(3) in tracheostoma volume resulted in a decrease of 21% in median adhesive lifetime (95% confidence interval 10-31%). CONCLUSIONS: Longer lifetime of the adhesive baseplate in patients with smaller volume outcomes suggests that a more accurate fit between baseplate and stoma leads to better fixation. This should be taken into account when shaping a stoma during laryngectomy. On the other hand, a more custom-made patch that has a more accurate fit could increase the lifetime of fixation. We believe that our three-dimensional volumetric data can contribute to the development of such an adhesive.

This ex-vivo study evaluates the feasibility of diffuse reflectance spectroscopy (DRS) for discriminating tumor from healthy tissue, with the aim to develop a technology that can assess resection margins for the presence of tumor cells during oral cavity cancer surgery. Diffuse reflectance spectra were acquired on fresh surgical specimens from 28 patients with oral cavity squamous cell carcinoma. The spectra (400 to 1600 nm) were detected after illuminating tissue with a source fiber at 0.3-, 0.7-, 1.0-, and 2.0-mm distances from a detection fiber, obtaining spectral information from different sampling depths. The spectra were correlated with histopathology. A total of 76 spectra were obtained from tumor tissue and 110 spectra from healthy muscle tissue. The first- A nd second-order derivatives of the spectra were calculated and a classification algorithm was developed using fivefold cross validation with a linear support vector machine. The best results were obtained by the reflectance measured with a 1-mm source-detector distance (sensitivity, specificity, and accuracy are 89%, 82%, and 86%, respectively). DRS can accurately discriminate tumor from healthy tissue in an ex-vivo setting using a 1-mm source-detector distance. Accurate validation methods are warranted for larger sampling depths to allow for guidance during oral cavity cancer excision.

Objectives/Hypothesis: To determine whether definitive radiotherapy prior to surgery increases the rate of pharyngocutaneous fistula (PCF) following laryngectomy or hypopharyngectomy and to determine if differences in duration of time between definitive radiotherapy and surgery alters PCF rate. Study Design: A retrospective review of 152 patients treated surgically for primary laryngeal or hypopharyngeal squamous cell carcinoma. Methods: Following previous definitive radiotherapy treatment 38 patients underwent salvage surgery and 114 patients underwent primary surgery with curative intent. The PCF rate was assessed in both groups. Results: The rate of PCF was found to be significantly higher in the salvage surgery group than those undergoing primary surgery (34.2% vs. 15.7%) (P 64 Gy) or concurrent chemoradiation are at high risk of developing PCF.

The aim of the study was to analyse the clinical outcome of patients treated surgically for oral carcinoma. A retrospective cohort study was undertaken of 356 patients with oral cavity cancer whose clinicopathological information had been collected prospectively onto a dedicated head and neck database. Disease recurrence and survival were assessed. Neck metastases occurred in 42% of patients. Tumour thickness (both 2 and 5 mm) predicted the presence of nodal metastases. Both pathological T stage (P < 0.001) and tumour thickness cut-off of 5 mm (P = 0.03) were independent predictors of disease-specific survival. With a median follow up of 41 months, overall survival at 5 years was 59% and disease-specific survival was 73%. Patients with thick tumours have a high risk of nodal metastases and this supports the liberal use of elective selective neck dissection in patients with clinically negative necks.

Conclusion. 3D stereophotogrammetry is a useful tool for quantitative assessment of tracheostoma anatomy, and thus in future could possibly play a role in solving current problems with peristomal and intratracheal fixation of stoma appliances. Objectives. Differences in tracheostoma anatomy between laryngectomized patients are held partly responsible for the differences in duration of attachment of standard peristomal adhesives for heat and moisture exchangers (HMEs) and automatic stoma valves (ASVs). Accurate information on a set of basic stoma anatomy parameters should be helpful to overcome fixation problems in individual patients and in the general laryngectomy population. Patients and methods. This was an exploratory observational pilot study in 20 laryngectomized patients. Three-dimensional (3D) images of the tracheostoma and surrounding tissue were captured with a 3D digital camera, which applies the advanced principles of stereophotogrammetry. Data were analysed by using a 3D editing program. The following tracheostoma parameters were measured for each patient: horizontal and vertical diameters, circumference, depth and surface. Results. Inter-observer outcomes show a mean stoma circumference of 58.2 mm (SD 11.6 mm). The mean surface was calculated at 186.6 mm2 (SD 61 mm(2)). The mean size of the stoma's horizontal diameter and vertical diameter was 14.7 mm (SD 2.9 mm) and 19.0 mm (SD 3.4 mm), respectively. The mean depth of the stoma in relation to the right sternal head of the m. sternocleidomastoideus was 15.5 mm (SD 5.4 mm) and in relation to the left it was 16 mm (SD 5.6 mm).

The majority of laryngectomy patients fail to use a hands-free valve on a daily basis, mainly due to fixation problems of the adhesive baseplate housing. To support adhesive housings during hands-free speech a new external neck brace (ENB 2.0) was developed. The effect of the brace was assessed in terms of a qualitative assessment, adhesive lifetime, maximum phonation time and patient self-reports.Twenty laryngectomees participated in this randomized, prospective, crossover trial.All participants used the Provox hands-free HME valve with an Xtrabase adhesive for 1 month, 2 weeks with an ENB 2.0, and 2 weeks without. Outcomes were compared with the previous model of the external neck brace (ENB 1.0).The average total number of adhesive baseplates used during the trial was 16.7 in the non-brace group versus 10.9 in the brace group (P = 0.05). The number of daily replacements was 1.4 in the non-brace group and 1.1 in the brace group (P = 0.025). The average time a hands-free valve was worn per baseplate was 9.5 hours when wearing a neck brace versus 7.3 hours without brace (P = 0.09).The majority (81%) of the patients considered the neck brace 2.0 as a welcome addition to improve hands-free speech after laryngectomy and would use it if prescribed (88%).The new model of the neck brace reduces the number of baseplate replacements during hands-free speech and is considered as a helpful device by 81% of the participants.

Objectives/Hypothesis:Assessment of a novel adhesive baseplate (Provox StabiliBase) for heat and moisture exchanger (HME) and/or automatic speaking valve (ASV) application.Study Design:Prospective, clinical, multicenter trial.Methods:This was a trial in laryngectomized patients comparing their usual adhesive with the trial adhesive. Primary outcome measure was overall patient preference; additional outcome parameters possibly explaining patients' preferences were 1) patient tolerance and preference with respect to daily handling of the adhesive; 2) adhesive lifespan, and 3) voice and speech with the adhesives. Study specific questionnaires, visual analog scales, patients' diaries, and stoma assessments were used for data collection.Results:In total, 58 of the 65 laryngectomized individuals entered in the study completed the trial. Patients' overall preference for the new device was high (76%; P < .001). Significantly better performance was found for the trial adhesive with respect to ease of application (P = .034), fit (P < .001), and air leakage through the adhesive (P < .001). Comfort and stoma depth correlated weakly (r = 0.297; P = .024; deeper stoma-more comfort with StabiliBase). The adhesive lifespan with HME is significantly increased (1.7 times and 15.7 hours-plus airtight use; P < .001). This longer lifespan coincided with somewhat increased dirtying of the adhesive (P = .02). There were no serious adverse events.Conclusions:The StabiliBase adhesive for peristomal attachment of HMEs and/or ASVs was preferred by 76% of study participants and showed a promising prolonged lifespan. This new device further increases the options for stoma attachment in laryngectomized individuals, and subsequently the availability of optimal voice and pulmonary rehabilitation for a larger proportion of patients.

Contains fulltext : 88127.pdf (Publisher’s version ) (Closed access) CONCLUSION: The external neck brace (ENB) is a new concept in the improvement of peristomal fixation of an automatic stoma valve (ASV), which was evaluated with a new imaging method. The addition of the ENB to the Flexiderm (FLD) and Xtrabase (XB) adhesives significantly reduced absolute mean differences between the speech and the non-speech conditions. OBJECTIVES: After total laryngectomy, peristomal fixation problems of adhesives and stoma valves are still the main reasons for the relatively small number of patients that actually use an ASV on a daily basis. Several concepts could not prevent these fixation problems. To overcome or at least diminish these attachment problems, an ENB has been developed to support peristomal adhesives. The mechanism behind this brace is that it absorbs the high stomal pressures created during tracheoesophageal speech. In this pilot study the mechanism outlined above was objectified using 3D stereophotogrammetrical measurements. METHODS: This was a prospective clinical pilot study in a university hospital setting, involving nine laryngectomized patients. Ten 3D images were taken of all patients using stereophotogrammetry; five pictures during a moment of speech and five during a non-speech condition. Two different peristomal adhesives were used during these two conditions: the Provox Flexiderm (FLD) adhesive and the Provox Xtrabase (XB) adhesive, both with and without the addition of the ENB. Besides these four combinations, a final fifth set-up using all the components (FLD + XB-ring + ENB) was added. Absolute mean differences were compared between two photographs of the area of interest, which is covered by the adhesive for all five different set-ups mentioned above. This was done during speech and non-speech conditions. RESULTS: Absolute mean differences at the region of the base plate between speech and non-speech conditions were most obvious while using just the FLD adhesive (4.70 mm). The use of the ENB significantly reduced the absolute mean difference to 0.58 mm (p < 0.02). The suggested set-up with a basis of the FLD adhesive combined with the solid ring extracted from the XB adhesive and the ENB showed the smallest absolute mean difference of 0.38 mm between speech and non-speech conditions (p < 0.025). 01 juli 2010

Objective: The prognostic impact of mandibular invasion by oral squamous cell carcinoma (SCC) is controversial. The objective of this study was to assess the effect that extent of bone invasion has on recurrence and survival in patients treated with marginal and segmental mandible resection. Study Design: A retrospective cohort study of patients whose clinicopathologic information had been collected prospectively into a dedicated head and neck database. Methods: Local control and disease-specific survival were retrospectively reviewed in 111 patients (median follow-up, 44 months) with oral SCC undergoing marginal or segmental mandibulectomy. Results: Bone invasion was present in 46% of marginal and 94% of segmental resections. Five-year local control was similar following marginal (83%) and segmental mandibulectomy (86%). There was no correlation with presence or extent of bone invasion. Survival at 5 years was 71% and this correlated with bone invasion and involved margins (P < .05), but not with extent of mandible invasion or resection. Conclusions: Marginal mandibulectomy does not adversely alter outcome in selected patients with bone invasion provided margins are not compromised.