A comparison of the Thunderbeat and standard electrocautery devices in head and neck surgery: a prospective randomized controlled trial.

PURPOSE: New energy-based sutureless vessel ligation devices, such as the Thunderbeat (Olympus Medical Systems Corp., Tokyo, Japan), could reduce operative time and limit blood loss in head and neck surgery; however, efficacy and safety in major head and neck surgery have not been investigated in a prospective, randomized study. METHODS: This prospective, double-arm, randomized controlled trial consisted of two parts: total laryngectomy (TL) and neck dissection (ND). Thirty patients planned for TL were randomized in two groups. For the ND part, forty-two operative sides were likewise randomized. In both parts, Thunderbeat was used in addition to the standard instrumentation in the intervention groups, while only standard instrumentation was used in the control groups. Primary outcome values were blood loss, operative time and complication rate. RESULTS: For the TL part there was no difference in mean blood loss (p = 0.062), operative time (p = 0.512) and complications (p = 0.662) between both hemostatic techniques. For the neck dissection part, there was a reduction in blood loss (mean 210 mL versus 431 mL, p = 0.046) and in operative time (median 101 (IQR 85-130) minutes versus 150 (IQR 130-199) minutes, p = 0.014) when Thunderbeat was used. There was no difference in complication rate between both hemostatic systems (p = 0.261). CONCLUSION: The Thunderbeat hemostatic device significantly reduces operative blood loss and operative time for neck dissections, without increase in complications. In TL, blood loss using Thunderbeat was comparable with the standard technique, but the operative time tended to be shorter. TRIAL REGISTRATION: UMCG Research Register, Reg. no. 201700041, date of registration: 18/1/2017.

Short- and long-term complications of surgical and percutaneous dilatation tracheotomies: a large single-centre retrospective cohort study.

OBJECTIVES: The aim of this study was to determine and compare the incidence of long- and short-term complications of percutaneous dilatation tracheotomies (PDT) and surgical tracheotomies (ST). DESIGN: A single-centre retrospective study. PARTICIPANTS: 305 patients undergoing a tracheotomy (PDT or ST) in the University Medical Center Groningen from 2003 to 2013 were included. Data were gathered from patient files. MAIN OUTCOME MEASURES: Short-term and long-term complications including tracheal stenosis. RESULTS: The incidence of short- and long-term complications, including tracheal stenosis, was similar in both groups. Analysis of a small high-risk subgroup showed no difference in long-term complications. CONCLUSIONS: The rate of short- and long-term complications, including tracheal stenosis, is equal in PDT and ST. PDT is a safe alternative for ST in selected patients.

Age-specific incidence and treatment patterns of head and neck cancer in the Netherlands-A cohort study.

OBJECTIVES: To explore the incidence and treatment pattern of head and neck cancer in different age groups. DESIGN: Cohort study. SETTING: Netherlands Cancer Registry. PARTICIPANTS: All new primary head and neck cancer cases diagnosed between 2010 and 2014 were included and categorised into different age groups. MAIN OUTCOME MEASURES: Tumour site, stage, treatment modality, location of diagnosis and treatment. RESULTS: The study population was composed of 11 558 tumours. Oral cancer was the most common primary site (31%), followed by laryngeal (25%) and oropharyngeal cancer (22%). Ninety-six per cent of the entire study population was diagnosed and/or treated in a certified head and neck oncology centre which was lower in the 80+ population (92%). Multimodality treatment was less frequently applied with increasing age (eg oral cavity: 17% in 80+ vs 34% in 60-; P < .001). The percentage of patients not receiving tumour-directed treatment increased with age (eg oropharyngeal cancer: 25% in 80+ vs 6% in 80-; P < .001). CONCLUSIONS: This study confirms that less multimodal and tumour-directed treatment is applied with the increasing age of head and neck cancer patients.

Influence of surface roughness on silicone rubber voice prostheses on in vitro biofilm formation and clinical lifetime in laryngectomised patients.

OBJECTIVES: Evaluation of the influence of a smooth surface moulding technique of silicone rubber indwelling voice prostheses on in vitro biofilm formation and analysis of the clinical in situ lifetime. DESIGN: Biofilm formation on smooth and Groningen ultra low resistance (URL) prostheses was studied in an artificial throat model. The clinical lifetime of smooth voice prostheses was compared to the previous lifetime of URL by counting the number of replacements in a consecutive 6-month period in the same patient. PARTICIPANTS: Eleven laryngectomised patients in follow-up who required frequent replacement of their voice prostheses. SETTINGS: Tertiary University Medical Center. RESULTS: Use of a smoother mould and less viscous silicone rubber yielded a decrease in surface roughness from 46 to 8 nm and was accompanied by a 40% reduction in the prevalence of bacteria and yeast in in vitro formed biofilms. Clinically, the lifetime was significantly (P<.005) increased by a factor of 2.1. CONCLUSIONS: This combined in vitro and clinical study suggests that the choice of material and in particular its surface finishing may be determining factors with respect to the clinical lifetime of silicone rubber implants and devices failing due to biofilm formation.

Clinical feasibility study of protrach dualcare a new speaking valve with heat and moisture exchanger for tracheotomized patients.

Objective: The aim of this study was to evaluate the clinical feasibility of the ProTrach DualCare (Atos Medical, Hörby, Sweden), a device combining a hands-free speaking valve and a Heat and Moisture Exchanger (HME) for tracheotomized patients. Study Design: A non-randomized, prospective single center feasibility study. Methods: Sixteen adult tracheotomized patients were included. Participants were asked to test the DualCare for two weeks while continuing their normal activities. After these two weeks, participants could choose whether or not to take part in the long-term evaluation. The EuroQOL-5D, Borg scale and questionnaires on speaking, pulmonary function and patient preference were used. During the long-term evaluation, a minor redesign was implemented and all participants were asked to test the new device again for one week, with a potential long-term evaluation. Eleven decided to participate. Results: The device was well-tolerated. Speaking noise was reduced (p = 0.020) and speech was considered to sound more natural compared to previously used devices according to the users (p = 0.020). Overall 11 participants preferred the DualCare to their standard device. No serious adverse events were reported. Conclusion: Overall, 11 of 16 participants preferred the DualCare to their standard speaking valve or HME. Users of the DualCare were able to use hands free speech with the benefits of an HME and the device was considered clinically feasible and has the potential to improve quality of life of tracheotomized patients. Level of Evidence: 2b.

Clinical outcome of salvage neck dissections in head and neck cancer in relation to initial treatment, extent of surgery and patient factors.

OBJECTIVE: Salvage surgery has a higher complication rate compared to primary surgical treatment. We evaluated clinical outcome of salvage neck dissections in relation to initial treatment modality, extent of surgery and patient-related factors. DESIGN: Single institution consecutive case series. SETTING: Tertiary Head and Neck Cancer Centre. PARTICIPANTS: In all, 87 patients with head and neck squamous cell carcinoma, who underwent salvage neck dissection after initial radiotherapy (n = 30), radiotherapy with carboplatin/5-fluorouracil (n = 43) or radiotherapy with cetuximab (n = 14). MAIN OUTCOME MEASURES: Incidence of complications, disease-specific survival. RESULTS: Complications occurred in 28% of the patients. Multivariate analysis identified extent of neck dissection as the only independent predictor of surgical complications (P = 0.010). Surgical complication rate was 16% after radiotherapy with systemic treatment, and 47% after radiotherapy alone (P = 0.171). The 5-year disease-specific survival was 55%, independent of complications, initial treatment, extent of surgery and patient-related factors. CONCLUSION: The only predictor for surgical complications was extent of surgery. Survival was not influenced by complications.

A prospective multicenter clinical feasibility study of a new automatic speaking valve for postlaryngectomy voice rehabilitation.

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.

Detection of HPV-associated oropharyngeal tumours in a 16-year cohort: more than meets the eye.

BACKGROUND: Accurate assessment of the prevalence of the human papilloma virus (HPV) in oropharyngeal tumours (OpSCC) is important because HPV-positive OpSCC are consistently associated with an improved overall survival. Recently, an algorithm has become available that reliably detects clinically relevant HPV in tumour tissue, however, no complete cohorts have been tested. The aim was to determine the prevalence of active high-risk HPV infection in a complete cohort of OpSCC collected over a 16-year period. METHODS: Using a triple algorithm of p16 immunohistochemistry, HPV-BRISH and HPV-PCR, we assessed the prevalence of active HPV infection in all OpSCC diagnosed in our hospital from 1997 to 2012 (n=193) and a random selection of 200 oral tumours (OSCC). RESULTS: Forty-seven OpSCC (24%) were HPVGP PCR-positive; 42 cases were HPV16+, 1 HPV18+, 3 HPV33+ and 1 HPV35+. Brightfield in situ hybridisation did not identify additional HPV-positive cases. Human papilloma virus-associated tumour proportion increased from 13% (1997-2004) to 30% (2005-2012). Human papilloma virus-positivity was an independent predictor for longer disease-specific survival (HR=0.22; 95%CI:0.10-0.47). Only one OSCC was HPV+. CONCLUSIONS: In our cohort, the incidence of HPV-associated OpSCC is low but increasing rapidly. The strict detection algorithm, analysis of disease-specific survival and the complete cohort, including palliatively treated patients, may influence the reported prevalence and prognostic value of HPV in OpSCC.

Early feeding after total laryngectomy results in shorter hospital stay without increased risk of complications: a retrospective case-control study.

OBJECTIVES: To evaluate the effects of a reduced nil per os (NPO) period after total laryngectomy (TLE) on general and wound-related post-operative complications, swallowing function and duration of hospital stay. DESIGN, SETTING AND PARTICIPANTS: In a retrospective case-control study in 71 patients after TLE with primary closure (i e. without reconstruction with tissue transfer), complications and hospitalisation in 36 patients who started oral feeding on days 3-5 (early feeding) were compared with 30 patients who started oral feeding on days 7-10 (late feeding). MAIN OUTCOME MEASURES: Incidence of complications, swallowing function and duration of hospitalisation. RESULTS: There were no significant differences between the early- and late-feeding groups in the occurrence of pharyngocutaneous fistulae, neopharyngeal stenosis or wound complications in general. Swallowing function was comparable for both groups. Mean overall hospitalisation was 2 days shorter in the early-feeding group (mean: 17.4 days) as compared to the late-feeding group (mean: 19.4 days) (P < 0.05). CONCLUSIONS: Early feeding after TLE without flap reconstruction did not contribute to an increase in complications and led to a shorter hospital stay.

Predictive value of the Groningen Frailty Indicator for treatment outcomes in elderly patients after head and neck, or skin cancer surgery in a retrospective cohort.

OBJECTIVES: Careful selection of patients eligible for extensive head and neck cancer surgery is extremely important. A reliable predictor for postoperative outcomes in the vulnerable elderly population is not yet available. The concept of frailty describes a clinical state of increased vulnerability and can be assessed using frailty tests, such as the Groningen Frailty Indicator. In the current study, the influence of Groningen Frailty Indicator-measured frailty on clinical outcome was investigated in elderly patients surgically treated for head and neck cancer. DESIGN: Retrospective, explorative cohort study. SETTING: Tertiary referral centre. PARTICIPANTS: A total of 90 patients of 65 years and older receiving surgical treatment for head and neck cancer with different primary sites. MAIN OUTCOME MEASURES: The influence of frailty (Groningen Frailty Indicator) on postoperative complications (Clavien-Dindo classification), subjective postoperative experience of both patient and surgeon and survival were analysed. RESULTS: A total of 36 patients were considered as frail (40%). Postoperative complications could not be predicted by frailty status. However, the Groningen Frailty Indicator dimension 'health problems' was a significant predictor for postoperative complications (P = 0.020). Unlike age and comorbidity, frailty was associated with a poor subjective patients' experience of the postoperative recovery (P < 0.01). Although not statistically significant, survival analysis showed a worse 5-year overall survival in the frail group (33%) versus the non-frail group (74%). CONCLUSIONS: Analysis of frailty could identify elderly patients who might suffer more than expected during the postoperative period after head and neck cancer surgery. In this study, frailty was not identified as a new predictor of complications after head and neck cancer surgery.

Lack of claudin-7 is a strong predictor of regional recurrence in oral and oropharyngeal squamous cell carcinoma.

OBJECTIVES: Adequate treatment of oral and oropharyngeal squamous cell carcinoma (OSCC) is dependent on correctly predicting the presence of lymph node metastases. Current methods to diagnose nodal metastases partly result in overtreatment with associated morbidity and undertreatment with decreased disease-free survival. E-cadherin has been studied extensively as potential marker for lymph node metastases. EpCAM and claudin-7 have a functional relationship with E-cadherin, forming a complex that promotes tumourigenicity in vitro. We hypothesize that the co-expression patterns of these related molecules is a better prognostic marker for nodal status and regional recurrences. MATERIALS AND METHODS: We constructed separate tissue microarrays of tumour centre and tumour invasive front of 227 OSCC with complete clinicopathological and follow-up data, including HPV status, and performed immunohistochemistry for these molecules. RESULTS: Lack of E-cadherin and presence of cytoplasmic EpCAM expression in the tumour front were predictive for nodal metastasis, but no co-expression pattern was found clinically relevant. Lack of claudin-7 in the tumour centre was highly and independently predictive for shorter regional disease-free survival (HR=0.19; 95%CI: 0.06-0.62) and disease-specific survival (HR=0.43; 95%CI: 0.21-0.87). High-risk HPV was not associated with any marker. CONCLUSIONS: The expression of E-cadherin and EpCAM, depending on the specific tumour sublocalization, is predictive for nodal status. However, co-expression did not improve the prediction of nodal status, indicating that the proposed in vitro complex is not functional in clinical samples. Additionally, lack of claudin-7 expression in the tumour centre may be used to identify patients with increased risk for regional recurrence.

Functional buckling behavior of silicone rubber shells for biomedical use.

BACKGROUND: The use of soft elastic biomaterials in medical devices enables substantial function integration. The consequent increased simplification in design can improve reliability at a lower cost in comparison to traditional (hard) biomaterials. Functional bi-stable buckling is one of the many new mechanisms made possible by soft materials. The buckling behavior of shells, however, is typically described from a structural failure point of view: the collapse of arches or rupture of steam vessels, for example. There is little or no literature about the functional elastic buckling of small-sized silicone rubber shells, and it is unknown whether or not theory can predict their behavior. Is functional buckling possible within the scale, material and pressure normally associated with physiological applications? An automatic speech valve is used as an example application. METHOD OF APPROACH: Silicone rubber spherical shells (diameter 30mm) with hinged and double-hinged boundaries were subjected to air pressure loading. Twelve different geometrical configurations were tested for buckling and reverse buckling pressures. Data were compared with the theory. RESULTS: Buckling pressure increases linearly with shell thickness and shell height. Reverse buckling shows these same relations, with pressures always below normal buckling pressure. Secondary hinges change normal/reverse buckling pressure ratios and promote symmetrical buckling. All tested configurations buckled within or closely around physiological pressures. CONCLUSIONS: Functional bi-stable buckling of silicone rubber shells is possible with adjustable properties in the physiological pressure range. Results can be predicted using the proposed relations and equations.

FADD expression is associated with regional and distant metastasis in squamous cell carcinoma of the head and neck.

AIMS: The Fas-associated death domain gene (FADD) is often overexpressed in squamous cell carcinoma of the head and neck (HNSCC), and is considered to be a driver gene in amplification of the chromosomal 11q13.3 region. Amplification of 11q13.3 is associated with increased metastasis in HNSCC and breast cancer. The aim of this study was to investigate the association between FADD protein expression in advanced-stage HNSCC and clinicopathological features and outcome. METHODS AND RESULTS: Tumour tissues of 177 HNSCC patients uniformly treated with primary surgery and postoperative radiotherapy were collected. FADD expression was assessed on pretreatment tumour biopsies using immunohistochemistry. High FADD expression was detected in 44% of the HNSCC patients. High expression was associated with an increased rate of lymph node metastasis (P = 0.001) and with a shorter distant metastasis-free interval (DMFI) (HR 2.6, 95% CI 1.0-6.7, P = 0.046) when lymph node metastases were present. CONCLUSIONS: Our data show that an increase in FADD expression is associated with a higher incidence of lymph node metastasis at presentation, and with shorter DMFI when lymph node metastases are present. High FADD expression in the primary tumour could be a useful marker to select patients for systemic treatment strategies that reduce the risk of distant metastases.

Age of diagnosis and evaluation of consequences of submucous cleft palate.

OBJECTIVES: To evaluate the frequency of submucous cleft palate (SMCP) in a group of children with clefts. The reason for suspecting submucous cleft, age of diagnosis, effect of age on speech development, problems in speech, hearing and swallowing were compared with previous literature. METHODS: Retrospective chart review: Out of 33 patients with SMCP, registered by the Groninger cleft team over approximately 20 years (1990 until July 2012), 28 non-syndromic patients with a proven diagnosis of SMCP were included: 17 males and 11 females. Speech and hearing were examined and the number of patients with SMCP and age at time of diagnosis were evaluated. The percentages of problems in resonance, articulation and hearing, present at time of diagnosis, were compared with the percentages of problems found after surgery. RESULTS: Out of 800 patients with clefts, 28 patients (3,5%) were diagnosed with SMCP at a mean age of 3;9 years. All patients presented one or more symptomatic complaints at time of diagnosis: hypernasality (65%), problems in articulation (46%), conductive hearing loss (39%) and/or swallowing problems (32%). A bifid uvula was found in 92%. Following surgery, hypernasal speech and swallowing problems were no longer observed. The articulation problems remained after surgery. Age of diagnosis seems no predictor of articulation problems. An improvement in hearing was observed but normal hearing was not achieved. Pharyngoplasty appeared to be a successful and save treatment of hypernasality. CONCLUSIONS: SMCP is a rare cleft palate which is, despite the presence of a bifid uvula and symptoms of velopharyngeal insufficiency, often diagnosed late. In children with a bifid uvula and mild problems in speech, hearing and swallowing, it is important to be alert to SMCP because SMCP may account for these persistent mild complaints. Therefore, early detecting of SMCP can yield profits.

Tumour infiltration depth ≥4 mm is an indication for an elective neck dissection in pT1cN0 oral squamous cell carcinoma.

Patients with pT1cN0 oral squamous cell carcinomas (OSCC) are generally not treated with a neck dissection (ND). However, in 25% of cN0 patients, nodal metastases become apparent during follow-up. Infiltration depth of the primary tumour has been consistently associated with the presence of nodal metastasis, but proposed cut-off depths for performing a ND vary considerably. The aim of this study was to explore the infiltration depth as predictor for the nodal status and to recommend a cut-off depth for performing a ND. From our database of 351 primary oral carcinomas, we selected all pT1-2 tumours (n=246). Infiltration depth was measured in 212 cases. Neck status was determined by histopathological examination of the dissection specimen, or by at least two years of follow-up. Mean infiltration depth was 5.49 mm (95% CI: 4.86-6.12) in the N0 and 8.40 mm (95% CI: 7.38-9.43) in the N+ group (p<0.001). cN status, lymphovascular invasion and infiltration depth were the only independent predictors for nodal status in multiple logistic regression. ROC-analysis on pT1cN0 tumours resulted in an optimal cut-off for the prediction of the nodal status at a depth of 4.59 mm. This cut-off identified a subgroup of patients at increased risk for nodal metastasis (OR=8.3) and with significantly shorter survival. Tumour infiltration depth is an independent predictor for nodal status in pT1-2 OSCC. In pT1cN0 tumours, a cut-off at 4.59 mm results in the best predictive value. We recommend an infiltration depth of ≥4 mm as an indication to perform a neck dissection in pT1cN0 OSCC.

Does the patch fit the stoma? A study on peristoma geometry and patch use in laryngectomized patients.

OBJECTIVE: To determine the geometry of (peri)stomas of laryngectomized 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 laryngectomized 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 laryngectomized patients. SETTING: Ten hospitals or institutes in eight countries. PARTICIPANTS: About 191 laryngectomized 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.