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Improving Hands-Free Speech Rehabilitation in Laryngectomized Patients with a Moldable Adhesive
Abstract
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.
... To improve fixation of the ASV, a moldable peristomal adhesive has recently been developed. Although a recent multicenter study has shown encouraging results [20], this device has not yet been marketed. The limited duration of the adhesive during the use of ASV, however, does not seem to be the only determining factor for poor patient compliance. ...
... The structured questionnaires used were developed for an our previous multicentric study [20] and contained questions that ensured the collection and analysis of both positive and negative results. The questionnaires were designed to be completed by the subject, both before and after the experimental training. ...
... Unfortunately, the instability of the adhesive and the high back pressure necessary for the phonation mean that only a minority of patients are able to achieve this therapeutic goal [11,12]. Several effort have been provided to increase the adhesion without simultaneously increasing of skin irritation, however up to date not a reliable solution has been found [20]. Therefore, it was decided to develop a new approach strategy starting from the causes most commonly reported by patients with the aim of increasing the frequency of use of the automatic device in our cohort. ...
Purpose
Aim of this study was to calculate the percentage of the Automatic Speaking Valve (ASV) use in a large cohort of laryngectomized patients with voice prosthesis (VP) and to analyze the main reasons for non-use. Subsequently, a specific rehabilitation training was proposed.
Methods
One hundred-ten laryngectomized patients with VP were enrolled in the first phase of the study (census). Among them, 57 patients were included in the second phase (intervention), in which a training based on moving phonatory exercises was proposed. Structured questionnaires were used before and after training in order to investigate ASV use rate (days/week and hours/day; reasons for impeding the ASV use), average adhesive life-time during ASV use; hands-free speech duration; skin irritation. Patients also expressed their degree of on a VAS scale from 0 to 100.
Results
In the census phase the percentage of use of ASV (everyday, without problems) was equal to 17.27% (19/110 patients). The main causes of disuse concerned excessive fatigue and poor durability of the adhesives. The analysis of the results pre vs. post-training showed a statistically significant increase (p < 0.05) in all the investigated parameters. Patients reported a good level of treatment compliance (average frequency of performing exercises equal to 4.2 ± 2.5 days/week for 1.4 ± 1.01 h/day) and high degrees of satisfaction. After treatment, the percentage of use of AVS increased by 43% reaching a rate of 60% (66/110 patients).
Conclusion
A specific and targeted approach that simulate the phonatory and breathing difficulties of everyday life can increase the ASV usage rate.
Total Laryngectomy seriously affects on patients Quality of Life and on their psychological well-being. The aim of this study was to verify the effects of pre-operative Speech-Language Pathology counselling on laryngectomized patients. Pilot randomized controlled trial. Twenty-seven patients undergoing total laryngectomy and primary tracheoesophageal puncture were randomized as follows: 14/27 subjects were collocated in the Experimental group who received preoperative Speech-Language Pathology counselling and 13/27 in the Control group group that did not receive it. Two interviews and four questionnaires (Psychological Distress Inventory, Impact of Event Scale-Revised, Hospital Anxiety and Depression Scale, Italian-Self-Evaluation of Communication Experiences after Laryngeal Cancer) were administered immediately after surgery (T0), 1- (T1) and 3-months (T2) after hospital discharge in order to asses levels of distress, post-traumatic stress and anxious-depressive symptoms, acquisition and acceptance of the new voice. Student’s t test and chi square test showed that the two groups of patients were equivalent. Experimental group was more satisfied with the information and obtained statistically better (p < 0.05) scores in terms of levels of distress, post-traumatic stress, anxious-depressive symptoms and acceptance of the new voice than the Control group. The Speech-Language Pathology counselling may reduce the anguish, sadness and anticipatory anxiety deriving from the uncertainty of the post-operative course and it might facilitate the process of emotional adaptation, making patients more capable and prepared to face their new condition.
Objective
Total laryngectomy (TL) leads to lifelong physical changes which can lead to functional and participation issues. To assess the relationship between self‐reported quality of life and functional and participation issues, a large international online questionnaire was used.
Method
A questionnaire was sent out to 8119 recipients of whom 1705 (21%) responded. The questionnaire consisted of 26 questions regarding demographic information, product use of the respondents, experienced overall health and independence, and functional and participation issues. Respondents were grouped based on sex, age, time since TL, educational level, and country of residence. Questions were grouped in one measure of reported quality of life (r‐QoL) and seven issue themes (“esthetic issues,” “experienced limitations in daily activities,” “avoiding social activities,” “communication issues,” “experienced vulnerability due to environmental factors,” “pulmonary issues,” and “sleep issues”) to assess the underlying relations.
Results
This study showed that more functional and participation issues and a lower r‐QoL are reported in the group of younger respondents (<60 years), women, and respondents who have had the TL procedure less than 2 years ago. The issue themes “experienced limitations in daily activities” and “avoiding social activities” are related to r‐QoL. Most participants report “pulmonary issues,” and these issues have a strong correlation with most other themes.
Conclusion
The ability to participate in meaningful and social activities is a major factor in r‐QoL. Due to the frequency and strong correlations of pulmonary issues with other issue themes, pulmonary issues might be an underlying cause of many other issues.
Level of evidence
3b
Background:
Physical and psychosocial challenges are common after total laryngectomy. The surgery leads to lifelong changes in communication, airway, swallowing and appearance. As we move towards health models driven by patient-centred care, understanding the differential impacts of surgical procedures on subgroups of patients can help improve our care models, patient education and support systems. This paper discusses the experiences of women following total laryngectomy.
Aims:
To gain an insight into the impact of total laryngectomy on women's daily life while identifying their specific rehabilitation needs.
Methods & procedures:
This paper is based on in-depth, semi-structured interviews with eight women who had undergone total laryngectomy. These interviews were conducted with women at least 1 year after they had undergone total laryngectomy, and the participants did not have recurrent disease. Using an interview guide, participants were encouraged to discuss their everyday experiences, while also focusing on issues typical to women. The transcribed interview data were analysed by thematic analysis, taking interpretative phenomenological analysis as a lead.
Outcomes & results:
The interviews revealed three main themes: disease and treatment as a turning point, re-establishing meaningful everyday activities, and persistent vulnerability. Participants reported experiencing challenges in their rehabilitation process due to physical disabilities, dependency on others and experienced stigma. Women-specific challenges arose in dealing with the altered appearance and voice, performing care activities, and the spousal relationship (including intimacy).
Conclusions & implications:
Women who undergo total laryngectomy are likely to experience issues in returning to work, the performance of informal care-work, the spousal relationship, intimacy and social interaction due to stigmatization. Medical pretreatment counselling and multidisciplinary rehabilitation programmes should help patients form realistic expectations and prepare them for the changes they will face. A gender- and age-matched laryngectomized patient visitor can contribute to this process. Rehabilitation programmes should incorporate the partner and offer psychosocial support for women following total laryngectomy to return to their former roles in family life, social life and work-related activities.
Introduction
Total laryngectomy has important psychophysical and social consequences for patients’ quality of life because of the functional changes resulting from the removal of the larynx. Voice deprivation is perhaps the most relevant limiting factor in social relationships, increasing feelings of solitude and tending to drive individuals into social isolation. Multiple voice rehabilitation methods after total laryngectomy are available. This study aimed to determine the acoustic quality of the rehabilitated voice achieved with esophageal speech (ES) and tracheoesophageal speech (TES), and acoustic quality impacts on patients’ perceptions of their quality of life.
Materials and methods
The patient inclusion criterion was the completion of a speech rehabilitation course with ES or TES at least 6 months after total laryngectomy. The voice acoustic analysis was carried out automatically by using the Multidimensional Voice Program. The following parameters were extracted: fundamental frequency (F0), Jitter% (Jitt), Shimmer% (Shim), and noise-to-harmonic ratio (NHR). Subjective voice evaluation was performed by using the following questionnaires: Voice Handicap Index (VHI), Voice-related Quality of Life (V-RQOL), and Voice Performance Questionnaire (VPQ).
Results
The acoustic analysis showed a difference between ES and TES patients on all acoustic parameters; this difference was significant for F0 (133.09±2.4 and 119±3.3, respectively; p<0.001), NHR (0.43±0.21 and 0.31±0.14, respectively; p=0.02), and maximum phonation time (2.02±038 s and 10.64±0.28 s, respectively; p=0.01. Regarding patient-related outcomes, TES correlated with better total scores compared with ES; however, the differences in the total scores on the VHI (p=0.09), V-RQOL (p=0.39), and VPQ (p=0.52) were not statistically significant.
Conclusion
The rehabilitation of laryngectomized patients must be addressed by a multidisciplinary team that considers the personalities, personal needs, and relational conditions of individual patients in order to determine and apply the phonatory rehabilitation method most suitable for achieving a better quality of life.
Background
Acquisition and acceptance of the alaryngeal voice, psychological state, and Quality of Life (QoL) of laryngectomized patients.
Methods
Thirty-two patients who underwent total laryngectomy were included in the study; 17 of them were treated by a psychologist and a speech therapist (experimental group); 15 performed only speech therapy (control group).
Results
The experimental group showed a significant improvement in all parameters of the INFVo scale, in the score of the Environment subscale and in the total score of the I-SECEL (Self-Evaluation of Communication Experiences after Laryngeal Cancer); in the Depression, Obsession-Compulsion and Paranoia areas of the SCL-90-R (Symptom Check List-90-Revised); and in the Social area (REL) of the WHOQOL-B (World Health Organization Quality of Life Scale–Brief).
Conclusions
An integrated rehabilitative approach to laryngectomized patients improves emotional state and psychosocial aspects and promotes acceptance and use of the new voice and recovery of a better quality of life.
In this article, we deal with the problem of potential stigmatization and social exclusion of people that have voice/speech problems due to neck cancer, especially those who have lost their voice because of total laryngectomy, and we analyze how this potential stigmatization could be alleviated by personalized speech synthesis. We used a mixed-method approach, consisting of quality of life questionnaires and in-depth semi-structured interviews, in order to provide more generalizable as well as rich information. We found out that people with speech problems feel depressed because of their health status and anxiety during social interactions, as they think that other people perceive them as abnormal, or they directly experience symbolic violence. For overcoming these negative feelings, the crucial factors are family relationships and maintaining employment. In both factors, speech synthesis can help significantly. Implications for rehabilitation Personalized speech synthesis can help considerably to people with severe voice impairment in their (re)integration into society. Where possible and appropriate, personalized speech synthesis should be offered as an option to "traditional" voice substitutions.
Evaluation of short- and long-term clinical feasibility and exploration of limitations and advantages of a new automatic speaking valve (ASV) for laryngectomized patients with integrated HME, the Provox FreeHands FlexiVoice (FlexiVoice). This ASV not only enables automatic, but also manual closure of the valve. A multicenter, prospective clinical study in 40 laryngectomized patients was conducted. Participants were asked to use the FlexiVoice for 26 weeks. The primary outcome measure was long-term compliance. Secondary outcome measures were: patient preference, hours of FlexiVoice use, device life of adhesive, voice and speech quality, and quality of life. After 26 weeks, 15 patients (37.5 %) were using the FlexiVoice on a daily basis, for a mean of 12.64 h/day (SD ± 5.03). Ten patients (25 %) were using the device on a non-daily basis, for a mean of 3.76 h/day (SD ± 2.07). The remaining 15 patients (37.5 %) discontinued using the FlexiVoice. Sixty percent of the 25 long-term users applied both automatic and manual closure of the valve. Unpredictable fixation of the adhesive was the main reason for discontinuing or not using the FlexiVoice on a daily basis. Overall, 18 patients (45 %) preferred the FlexiVoice, 16 patients (40 %) their usual HME, 3 patients (7.5 %) their usual ASV, 1 patient (2.5 %) preferred no device at all, and in 2 patients preference was not recorded. The minor technical issues identified could be corrected. The Provox FreeHands FlexiVoice appears to be a useful ASV, which allows for hands-free speech in a larger proportion of laryngectomized patients in the present cohort. The additional manual closure option of the device is beneficial for maintaining the adhesive seal longer.
Total laryngectomy (TL), a life-preserving surgery, results in profound physical and communication changes for the individual. Physical and psychosocial adjustment to a TL is complex, and quality-of-life (QoL) measures have provided useful knowledge to assist clinical management. However, many tools were developed without considering the perspectives of people who have experienced TL. To improve understanding of the phenomena of living with TL, a qualitative study was conducted which explored the views and experiences of seven men and five women from a range of ages, geographical locations, and social situations who had undergone a TL. Data were collected through in-depth, semi-structured interviews, journals, and field notes, and analysed using a constructivist grounded theory approach and symbolic interactionism. The emergent concept was identifying with the altered self after TL as reflected in dynamic multi-level changes (physical, communication, and psycho-emotional) continuously interacting with intrinsic and extrinsic interpersonal factors including personal and socio-cultural constructs, e.g., age, gender, resilience, beliefs, and supports. This process affected the strategies these individuals used to negotiate their social experiences. The extent to which communication changes disrupted social roles affecting a person's sense of self appeared to relate to long-term adjustment.
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.
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.
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.
Prospective trial in a university hospital setting.
Twenty-four laryngectomised patients.
Stoma volume in cm(3) and adhesive baseplate adherence in minutes.
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%).
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.
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.
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.
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.
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).
In most patients with advanced or recurrent laryngeal or hypopharyngeal cancer, total laryngectomy is indicated. This means the loss of three main functions: phonation; respiration; and the prevention of aspiration during deglutition. Laryngectomy patients have various options to restore phonation: an oesophageal voice; an electrolaryngeal voice; or a tracheo-oesophageal voice. In the last case a silicone rubber shunt valve is placed in the tracheo-oesophageal wall and phonation is generated when exhaled air is forced through the oesophagus and neopharynx. This method is widely applied in Western Europe. In this paper we review the literature on fixation problems with shunt valves, tracheostoma valves and heat and moisture exchange (HME) filters. Tracheo-oesophageal speech without a valve is not considered. Despite 22 years of experience with the implantation of tracheo-esophageal shunt valves and many improvements in the design, problems still remain, such as biofilm formation with subsequent leakage through the valve, the need for frequent and inconvenient replacements, fistula enlargement leading to leakage around the device and reduced fixation, and infections. The high cost of shunt valves is a drawback to their use worldwide. To enable hands-free speech, different types of tracheostoma valve have been developed. These valves are fixed to the skin or to the tracheostoma by means of an intra-tracheal device. An HME filter is used to protect the airway and maintain physiological balance. Such devices are only suitable for a selected group of patients as fixation to the skin or trachea can be a major problem. Speaking and coughing cause pressure increases, which often result in mucous leakage and disconnection of the valve and/or HME filter. Recommendations are made for future improvements in fixation techniques.
There are various options to restore phonation after laryngectomy; one option involves using tracheo-oesophageal voice by placing a speaking valve through the tracheo-oesophageal wall. Some patients struggle to obtain good fixation of an adhesive base plate to the skin; this can result in air leakage and poor voice. We describe a technique using a custom-made prosthesis to provide a better base plate for fixation of the heat and moisture exchange cassette. This technique involves making an impression of the anterior neck around the laryngectomy stoma to create an anatomically fitted prosthesis, which accurately fills the void around the stoma. The custom-made prosthesis provides a more individualised fit compared to a standard base plate, helping improve vocalisation and communication.
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.
Background:
Quality of life (QoL) is an important construct when assessing treatment outcomes.
Aims:
To examine the relative contributions of functioning, psychological well-being and self-efficacy on self-perceived QoL with a sample of total laryngectomy patients in Australia who had surgery for advanced laryngeal cancer.
Methods & procedures:
In a cross-sectional study, 113 members of the Laryngectomy Associations of New South Wales and of Victoria, Australia, were recruited, and each was sent a series of questionnaires for postal return. Four psychometrically validated measures were used for participants to document their QoL, functioning (speech, swallowing), psychological well-being and general self-efficacy.
Outcomes & results:
Eighty-six (77%) questionnaires were returned and 83 were analysed. The cohort consists of 70 men and 13 women aged between 46 and 88 years. Overall, this sample of total laryngectomy survivors demonstrated significantly reduced physical health QoL (p < 0.001) and social relationship QoL (p = 0.011) and higher levels of depression (p = 0.008) and anxiety (p = 0.001) when compared with normative samples. This was in the context of them having higher than normal self-efficacy scores and, at worst, mild (self-rated) impairment of speech and of swallowing. Psychological well-being (sr(2) = 0.43, p < 0.001) had a stronger association than functioning (speech, swallowing, sr(2) = 0.08, p < 0.05) for their psychological QoL. Psychological well-being (sr(2) = 0.17, p < 0.001) and not functioning (sr(2) = 0.05, p > 0.05) were significantly associated with social relationship QoL. Self-efficacy scores were significantly higher than norms in this cohort, but were not associated with either their psychological QoL or social relationship QoL, after controlling for psychological well-being and functioning.
Conclusions & implications:
For survivors of laryngeal cancer treated by total laryngectomy, it is important to be aware of the impact of psychological well-being (depression, anxiety, stress) on self-perceived QoL. In addition to rehabilitating function (speech, swallowing), specific interventions to assist these individuals better manage their psychological well-being will likely improve their perceived life satisfaction/QoL.
Purpose of review:
Total laryngectomy rehabilitation (TLR) in Europe is not uniform, with quite some differences in approach and infrastructure between various countries. In, for example, the Netherlands, Switzerland, Scandinavia, and more recently also in the UK, head and neck cancer (HNC) treatment and rehabilitation shows a high level of centralization in dedicated HNC centres. In other European countries, the level of centralization is lower, with more patients treated in low-volume hospitals. This article focusses on the situation in the Netherlands and, where applicable, will discuss the regional variations in Europe.
Recent findings:
Prosthetic surgical voice restoration (PSVR) presently is the method of choice in Europe, and use of oesophageal and electrolarynx voice has moved to the background. In most European countries (except the UK and Ireland), PSVR is physician driven, with an indispensable role for speech-language pathologists and increasingly for oncology nurses. Indwelling voice prostheses are mostly preferred, also because these devices can be implanted at the time of trachea-oesophageal puncture. Pulmonary rehabilitation is achieved with heat and moisture exchangers, which, based on extensive clinical and basic physiology research, are considered an obligatory therapy measure. In addition to PSVR, also issues such as smoking cessation, dysphagia/swallowing rehabilitation, and olfaction/taste rehabilitation are discussed. Especially, the latter has shown great progress over the last decade and is another example of increasing implementation of evidence-based practice in TLR.
Summary:
TLR has shown considerable progress over the last decades, and through the intensified collaboration between all clinicians involved, significantly has improved vocal, pulmonary, and olfactory rehabilitation after total laryngectomy.
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.
1b. Laryngoscope, 123:2209–2215, 2013
Öztürk, A. & Mollaoğlu, M. (2013). Determination of problems in patients with post-laryngectomy. Scandinavian Journal of Psychology. The purpose of this study is the determination of the physical and psychosocial problems of total and partial laryngectomies. A total of 25 patients, who were operated with the diagnosis of larynx carcinoma in 2010 at Gazi University Faculty of Medicine Otolaryngology Department, were included in the study. They were evaluated with the help of the Personal Information Form (PIF) and the Determination Form of Post Laryngectomy Problem (DFPLP) for the problems they encountered after the operation. Total laryngectomy (TL) was performed on 76% of patients. It was determined that patients undergoing total laryngectomy experienced some physical and psycho-social problems such as problems in sleep (31.6%), smell (52.6%), taste (36.8%), and difficulty in swallowing solid foods (36.8%). Furthermore in patients with TL surgery whilst 47.4% of them think that their sexual lives were affected rather negatively, this rate was determined as 33.3% in patients with partial laryngectomy surgery (PL). The psychosocial score averages of the patients who had smell and taste disorders were significantly lower (p < 0.05). The patients, who underwent a laryngectomy operation, experienced many physical, social, and psychological problems. Thus, medical personnel also need to pay attention to these concomitant problems that occur during the treatment of the primary disease and the application of necessary supplementary treatments such as voice prosthesis, pre-op and post-op counseling, and anti-depressants seems significant in terms of increasing the life quality of the patients.
Clin. Otolaryngol. 2011, 36, 235–241
Objective: To determine the geometry of (peri)stomas of laryngectomised patients in relation to patch use. This data will enable improvement of tracheostoma interfaces, specifically addressing patients currently unable to use stoma patches. The low use of Heat-and-Moisture-Exchange (HME) filters and (hands-free) speech valves, although very important to the quality of life of laryngectomised patients, is mainly attributed to poor fit of the adhesive patches to the stoma site. Current patch shapes are not based upon an objective (peri)stoma geometry because this geometry is unknown.
Design: Observational anthropometric study of the (peri)stoma of laryngectomised patients.
Setting: Ten hospitals or institutes in eight countries.
Participants: About 191 laryngectomised patients, at least 1 year post operative.
Main outcome measures: (Peri)stomas were photographed and measured. Patients completed a questionnaire on patch-use. Concavity of commercially available patches was measured.
Results: In countries with a financial reimbursement system 58% of the patients use patches, compares to only 9% in other countries. Patches stay in situ for an average of 33.3 h. Patch and non-patch users differ on five out of ten measured geometrical parameters. Most striking differences are that patch users have much shallower peristomas (13 versus 18 mm), and stomas far more parallel to the anterior neck plane. The deepest commercially available patch is only 7 mm deep.
Conclusions: This study provides detailed (peri)stoma geometry data of a divers population, and for the first time in relation to patch-use. It reveals a serious mismatch between patients and patches. With these data new patches can be developed that could dramatically improve rehabilitation after laryngectomy.
Background
Tracheostoma breathing valves permit hands-free tracheoesophageal (TE) speech production; however, few laryngectomees routinely use them because of problems with attachment.Methods
We retrospectively reviewed the charts of 45 TE speakers to determine the success rate and factors associated with successful breathing valve use based on attachment. All patients attempted to use a tracheostoma breathing valve with either a standard or customized peristomal housing, or a standard or customized Barton button. Device selection was based on inspection of the patient's neck and peristomal contour. Six to eight consecutive hours of attachment defined success.ResultsOverall, 9% of subjects succeeded with any peristomal attachment as compared to 68% with either a standard (57%) or customized (85%) Barton button. Smooth stomal contour, a contiguous stomal lip, and correct button length were important for successful Barton button use.Conclusions
Standard or customized Barton buttons offer excellent alternatives to peristomal housing attachments for hands-free TE speech in select patients. © 2000 John Wiley & Sons, Inc. Head Neck 22: 142–148, 2000.
This investigation focuses on the psychosocial concomitants of a laryngectomy. Semistructured interviews were conducted with 218 laryngectomized patients. Standardised questionnaires were used to assess patients' social activity (FPAL, EORTC QLQ-C30), intelligibility of speech (PLTT, FPAL), mental well-being (HADS), and perceived stigmatisation (FPAL). More than 40% of the patients withdrew from conversation. Only one-third of all patients regularly took part in social activities. About 87% perceived stigmatisation because of their changed voice and more than 50% felt embarrassed because of their tracheostoma. Almost one-third of the patients had increased anxiety and depression scores. Moderate objective speech intelligibility was found, though patients were not particularly satisfied with their voice. Social activity emerged to be independent from age, gender, treatment variables, and stage of disease. Multivariate analysis resulted in two independent factors representing two patterns of social withdrawal. On the one hand, there was withdrawal from conversation accompanied by increased depression and poor speech intelligibility. On the other hand, there were reduced social activities accompanied by increased anxiety and perceived stigmatisation.
The incidence and severity of respiratory symptoms after total laryngectomy and their influence on daily living were studied in 59 laryngectomized patients. Daily sputum production was the principal complaint of these patients (98%), followed by coughing (64%) and the need for frequent forced expectoration (more than 5 times a day) in order to clear the airway (57%). Frequent stoma cleaning (more than 5 times a day) was required by 37% of the patients. Significant correlation was found between respiratory symptoms, voice rehabilitation and several aspects of daily living, including fatigue, sleep problems, social contacts and psychological distress. These findings indicate that respiratory symptoms after total laryngectomy are both frequent and troublesome. The development of effective methods for minimizing and/or preventing such respiratory problems would contribute significantly to improving the quality of life of laryngectomized patients.
Functional changes after total laryngectomy, including voice quality, hyposmia and dysgeusia, nasal discharge, swallowing and smoking habits were studied by means of a structured interview with 63 laryngectomized patients. Eighty per cent of the patients reported that they were satisfied with the quality of their voice including speaking on the telephone. Significant correlations were found between the quality of the voice and fatigue, frequency of making telephone calls and anxiety about speaking (P < 0.01). Vocal rehabilitation was achieved in the majority of patients (78%) with the indwelling Provox™ voice prosthesis. Forty-five per cent of the patients complained about annoying eructation. Hyposmia was reported by 52% of the patients, while 15% experienced dysgeusia. A significant correlation was found between hyposmia and dysgeusia (R= 0.43, P < 0.001). All patients with a taste problem also reported a poor sense of smell. Daily nasal discharge was reported by 38% of the patients. Due to difficulties in swallowing solid food, about one quarter of the patients changed their diet. All but one patient had been heavy smokers pre-operatively. Only 9% continued to smoke post-operatively.
These results, along with the previously reported respiratory problems resulting from total laryngectomy, should be taken into account in counselling patients who are candidates for this surgical procedure.
To develop and test the prototypes of a novel post-laryngectomy rehabilitation tool incorporating an obligatory, disposable heat and moisture exchanger (HME) and a reusable, multi-magnet automatic speaking valve (ASV).
The study subjects comprised 20 laryngectomized individuals (15 males, 5 females), 5 of whom were already using an ASV and 15 who were not. Three successive prototypes were tested. Data were collected by means of structured questionnaires, considering for example patient compliance, skin adhesion, voicing and coughing aspects, and voice and speech quality assessments, assessing for example maximum phonation time and dynamic loudness range.
Of the 15 non-ASV users, 5 did not comply with the study due to peristomal skin adhesion problems. Of the remaining 15 patients, all 5 ASV users and 6/10 non-users were fully compliant with the new device. The cough-relief valve of the new device functions properly, as does the valve position adjustment for physical exertion. With this new device the maximum phonation time was longer than with a regular ASV (15.2 vs 11.6 s; p = 0.006) and the dynamic range was larger (33.0 vs 24.8 dB; p < 0.001).
The test results obtained with this new device show that its advanced features (obligatory HME and multi-magnet valve systems) offer additional benefits for further improving vocal and pulmonary rehabilitation after total laryngectomy.
For speech rehabilitation after total laryngectomy, the Provox FreeHands Heat and Moisture Exchanger (FreeHands HME; Atos Medical AB, Hörby, Sweden) was compared with the Provox Heat and Moisture Exchanger (HME), and the patients' Health-Related Quality of Life (HRQoL) was assessed. A review of the English literature was performed considering automatic speaking valves. The study design was a cohort study. Fourteen laryngectomized male patients who had used the HME successfully before receiving the FreeHands HME entered the study. An ENT specialist and a speech pathologist examined these patients. Data concerning voicing, breathing, skin adhesion, voice and speech quality, and HRQoL were collected by a structured questionnaire. Voice recordings were performed for evaluation of the quality of the voice. A computer-aided search of the MED-LINE database was conducted, supplemented by hand searches of key journals. Twelve patients had used the FreeHands HME on special social occasions and reported three main reasons why FreeHands HME was unsuitable for continuous use: heavier breathing, more difficult speaking, and worse subjective quality of voice. With HME, phonation time tended to be longer and the softest phonation softer ( P =0.034). The loudest phonation was louder with FreeHands HME ( P =0.015). Patients' HRQoL assessed by the 15D profile was similar to that of the age- and sex-matched male Finnish general population (patients 0.877, population 0.884). A review of the literature showed few works dealing with automatic speaking valves. The FreeHands HME is a useful additional device in a selected group of laryngectomized patients. Total laryngectomy did not lower patients' HRQoL notably.
With the use of a new automatic stoma valve (ASV) it appears possible to rehabilitate patients who have previously been unsuccessful in acquiring hands-free speech. As well as making daily ASV use possible for an additional group of patients, this new device was also appreciated by many patients as an additional rehabilitation tool for specific occasions. Despite statistically significant improvements in aspects of voice and breathing using this novel ASV, improvement of peristomal adhesion is probably the main factor needed to further increase success rates. Nevertheless, our results show that it makes sense to keep trying to achieve hands-free speech, even if previous attempts have failed.
To make a long-term (6 months) assessment of compliance and aspects of voice, breathing and quality of life using a new ASV: the Provox FreeHands heat and moisture exchanger (HME).
This was a prospective clinical multicentre trial in 79 laryngectomized patients (8 regular ASV users, 58 previously unsuccessful users and 13 new users). Data were collected at baseline and after 1 and 6 months by means of European Organization for Research and Treatment of Cancer Quality of Life questionnaires and specific structured questionnaires concerning compliance, skin adhesion, voicing and pulmonary aspects. An objective assessment of voice parameters (maximum phonation time, maximum phonation time while counting, dynamic loudness range and number of pauses in a standard read-aloud text) was made for comparison of different stoma occlusion methods (digital occlusion via an HME and two different ASVs). A subjective assessment of overall voice quality was made.
After 6 months, 19% of patients used the new ASV on a daily basis (mean 5 h/day), while 57% used it on an irregular basis as an additional rehabilitation tool for special occasions. Two-thirds of the study group indicated that they would continue to use the new ASV after the study period. With respect to the objective parameters, statistically significantly better maximum phonation times and dynamic loudness ranges were observed with the new ASV compared to the Blom-Singer ASV. However, the best results for all the objective parameters were obtained with digital occlusion via the Provox HME.
After total laryngectomy and voice rehabilitation using a tracheoesophageal shunt valve, patients often have valve-related complications such as leakage. To solve these problems, a tracheoesophageal tissue connector (TE-TC) was devised to serve as an interface between the patient's tissue (trachea and esophagus) and the shunt valve.
The TE-TC is a permucosal connection constructed from a titanium ring (filled with a silicon rubber plug) combined with polypropylene or titanium mesh. After implantation in adult goats for 12 weeks the implants were submitted to histologic investigation.
Firm implant fixation was achieved. In nearly all (18/19), no signs of infection of the implant were seen; 11 of 19 animals died before the end of the experiment owing to complications not related to the implant.
The TE-TC is a new device with potential in the solution for fixation-related problems in tracheoesophageal voice rehabilitation.
Excellent results have been reported with the use of voice prostheses for the rehabilitation of laryngectomees. Patients, however, consider it a disadvantage that the tracheostoma must be closed manually for speech production. This limits their ability to simultaneously communicate by gesture or to work with both hands. An automatic tracheostoma valve helps patients overcome this problem. We describe a prospective clinical trial evaluating our experience with the Provox FreeHands HME Automatic Tracheostoma Valve system. Twenty-four laryngectomees were randomly selected from the patients who had undergone laryngectomy at the ENT Department. Immediately, after 4 weeks and 6 months later having been fitted with a Provox FreeHands HME, the patients were asked to complete a questionnaire in order to assess their satisfaction, voice quality, wearing comfort, fixation, potential problems, and the effectiveness of the HME cassette. In addition, we investigated relevant voice quality parameters including dynamics range, frequency range of the speaking voice, and maximum phonation time. Seven patients discontinued the study due to problems of securing the valve to the skin (four patients) or recurrent cancer (three patients). Ten of the remaining 17 patients wore the valve daily for an average of 8.4 h. A total of 88% of the patients considered it a great advantage to be able to speak without having to use their hands. With the Provox FreeHands HME, maximum phonation time was 8.7 (+/-6.2) s and the dynamic range was 21.9 (+/-5.8) decibels. The results show that the Provox FreeHands HME Automatic Tracheostoma Valve system not only allows hands-free speech but is also associated with excellent compliance and good voice rehabilitation.
This newly developed tracheostoma button and fixation system was appreciated by the majority of the patients in this study and led to an increased use of automatic speaking valves (ASVs).
Development and prospective clinical evaluation of a new tracheostoma button and fixation system to enhance hands-free speech in laryngectomized patients.
The Provox LaryButton and LaryClip adhesive system were prospectively evaluated in 11 patients: 10 male, 1 female; mean age 60.5 years, range 46-80 years; median follow-up since laryngectomy 4.9 years, range 9 months to 21 years. A study-specific questionnaire was used and the observation period was 3 weeks.
Eight patients were compliant, three dropped out of the study. The LaryClip adhesive system was tried by seven of these compliant patients, and ultimately used by six. At the start of the study two patients used an ASV on a daily basis, three alternated between an ASV and regular, manually operated heat and moisture exchangers (HME), three only used a HME. At the end of the study, three used the ASV daily, five alternated between ASV and HME. Seven patients indicated that they would continue using the new system, six with clips and one with the button only.
Interaction of functional and participation issues on quality of life after total laryngectomy
- M Leemans
- KE Sluis
- RJJH Son
- MWM Brekel
Objective and subjective voice outcomes after total laryngectomy: a systematic review
- KE Sluis
- L Molen
- RJJH Son
- FJM Hilgers
- PA Bhairosing
- MWM Brekel