Treatment of supraglottic squamous cell carcinoma with advanced technologies: observational prospective evaluation of oncological outcomes, functional outcomes, quality of life and cost-effectiveness (SUPRA-QoL).

BACKGROUND: Over the past decade, therapeutic options in head and neck supraglottic squamous cell carcinoma have constantly evolved. The classical total laryngectomy has been partially replaced by alternative organ- and function-sparing techniques with the same prognosis but less morbidity, such as Radiotherapy, Transoral Laser Microsurgery (TLM) and Trans-Oral Robotic Surgery (TORS). Up to now, a prospective comparison of these innovant techniques has not been conducted. METHODS/DESIGN: We will conduct an original international multicentric prospective nonrandomized clinical trial to compare the efficacy between these treatments (Arm 1: Radiotherapy ± chemotherapy; Arm 2: TLM and Arm 3: TORS) with 4 classes of outcomes: quality of life (QoL), oncological outcomes, functional outcomes and economic resources. The population will include cT1-T2 /cN0-N1/M0 supraglottic squamous cell carcinoma. The primary outcome is a Clinical Dysphagia QoL evaluation assessed by the MD Anderson Dysphagia questionnaire. Secondary outcomes include others QoL evaluation, oncological and functional measures and cost parameters. The sample size needs to reach 36 patients per arm (total 108). DISCUSSION: In the current literature, no prospective head-to-head trials are available to compare objectively these different treatments. With the increase of highly efficient treatments and the increase of oncological survival, it is imperative also to develop management strategies that optimize QoL and functional results. We will conduct this innovate prospective trial in order to obtain objective data in these two main issues. TRIAL REGISTRATION: NCT05611515 posted on 10/11/2022 (clinicaltrial.fgov).

Transoral radiofrequency of the terminal branches of the recurrent nerve in the treatment of adductor spasmodic dysphonia: our experience over 11 patients.

PURPOSE: Spasmodic dysphonia (SD) or laryngeal dystonia is as a rare vocal disorder characterized by involuntary action-induced endolaryngeal contraction. In the last decade, botulin toxin injection has become the standard treatment in adductor spasmodic dysphonia necessitating repetitive injections. The purpose of this study is to analyze retrospectively data from patients treated with the minimal-invasive transoral radiofrequency-induced thermotherapy (RFITT) of the terminal branches of the recurrent nerve. METHODS: Between 2009 and 2015, 11 patients (six females and five males aged from 32 to 91 years) with adductor SD were treated with RFITT. Pre-operative and post-operative vocal assessments (VHI-30, GRBASI, and acoustic-aerodynamics measurements), number of surgical revisions, delay between procedures, and post-operative complications were recorded. Statistical analyses were carried out on the first vocal assessment performed 2-8 weeks after the first procedure. RESULTS: Based on available data from ten patients, voice handicap index (VHI) showed improvement with a mean value of -17.7 points (p-value (pval) = 0.014, adjusted p-value (adj pval) = 0.21); instability has also revealed improvement in six patients (pval = 0.05, adj pval = 0.31). Four patients underwent only one procedure including one patient showing still long-term beneficial results after 5 years of follow-up. Other patients required one to three new procedures with an average time between procedures of 15.3 months. Over 24 surgeries performed on a total of 11 patients, one definitive treatment-related severe adverse event was reported. CONCLUSION: Thanks to long-lasting effect, repetitive treatments are less frequent compared to botulin toxin therapy. In our opinion, RFITT is a promising alternative to botulin toxin as a second-step procedure in case of toxin resistance or patient's lack of compliance.

Very long-term Voice Handicap Index Voice Outcomes after Montgomery Thyroplasty: A cross-sectional study.

OBJECTIVE: The aim of this multicentric cross-sectional study was to examine the permanency of Montgomery thyroplasty (MTIS) results from a patient's perspective. DESIGN: The study consisted of collecting Voice Handicap Index (VHI-30) questionnaires from patients who had previously been operated with MTIS between 2 and 12 years before. Very long-term (>2 years) postoperative data were compared with the previously acquired preoperative and early postoperative VHI results. Influence of factors such as age, gender, size/side of the prosthesis and length of the follow-up were also analysed. SETTING: Multicentric study involving three tertiary European voice centres. PARTICIPANTS: Forty-nine unilateral vocal fold paralysis (UVFP) patients, treated by MTIS, were included in the study. MAIN OUTCOME MEASURES: The Voice Handicap Index-30 score. RESULTS & CONCLUSIONS: The median VHI was significantly different over time-points (Friedman's test P < .001), with a significant difference between preoperative and early postoperative time-points (median VHI: 70 vs 21, respectively; P < .001) and between preoperative and very long-term postoperative time-points (median VHI: 70 vs 16, respectively; P < .001). The median VHI did not differ for the early and very long-term postoperative time-points (median VHI: 21 vs 16; P = .470). Age differences, gender differences and size/side differences of the prostheses, centres where surgery took place and length of the follow-up showed no significant influence. Medialisation thyroplasty (MT) overall and MTIS, in particular, should be considered as a possible standard of care for UVFP when permanency of voice results is sought.

Tracheal damage.

Tracheal damage. Blunt/penetrating trauma and inhalation injuries to the trachea can result in acute airway compromise, with life-threatening implications. Early assessment, identification, and prompt and appropriate management are of paramount importance in order to reduce patient morbidity and mortality. Signs and symptoms of these injuries are specific and sometimes subtle, and their seriousness may be obscured by other injuries. Diagnosis can therefore be challenging, requiring a high index of suspicion. Indeed, diagnosis and treatment are often delayed, resulting in attempted surgical repair months or even years after injury. Laryngoscopy, flexible and/or rigid bronchoscopy and computed tomography of the chest are the procedures of choice for a definitive diagnosis. Airway control and appropriate ventilation represent the key aspects of emergency management. Definitive treatment depends on the site and the extent of injury. Surgery, involving primary repair with direct suture or resection and end-to-end anastomosis, is the treatment of choice for patients suffering from tracheal injuries. A conservative approach must be considered for the paediatric population and selected patients with mainly iatrogenic damage. We present a review of the incidence, mechanisms of injury, clinical presentations, diagnosis, initial airway management, anaesthetic considerations and definitive treatment in the case of tracheal damage from blunt/penetrating trauma and inhalation injuries.

Long-term complications after facial, pharyngeal, laryngeal and tracheal traumas.

Long-term complications after facial, pharyngeal, laryngeal and tracheal traumas. OBJECTIVE: To review and summarize the existing evidence for long-term anatomical and functional complications after pharyngeal, laryngeal and tracheal traumas. DATA SOURCES: The MEDLINE database and the bibliographies of relevant studies were selected, analysed and appraised prior to December 2015. METHODS: With regard to the search strategy, the selected items were: ((long-term complications) AND pharyngeal) AND laryngeal) AND tracheal) AND traumas. Abstracts and titles were screened for relevance, while full articles of the se- lected records were evaluated and critically appraised after inclusion. Data concerning life-threatening situations, as well as long-term severe adverse effects were collected.

Transoral robotic surgery (TORS) with the Medrobotics Flex™ System: first surgical application on humans.

Head and neck surgery can be fraught with difficulties in accessing the pharynx and larynx. Minimally invasive surgery has developed with the recent advances in technology. Currently, we have a variety of high-definition multichannel videoendoscopes and robots in our armamentarium. We present our experience in a new robotic surgical system-'The Medrobotics Flex™ System' at our tertiary referral unit. We aimed to assess the safety, functionality and ease of use of this new device in this prospective study. Thus far, this is the first study in live human subjects who have undergone surgery for the following conditions: (1) obstructive sleep apnoea involving the base of tongue, the tonsil and the velum; (2) vocal fold polyp; (3) carcinoma of the lateral edge of the tongue. There were no complications in our series and the system provided good visualisation and access to these subsites without compromising safety or success. In summary, we found the Medrobotics Flex™ System to have certain other advantages including ease of set up and use besides being reliable and safe.

The da Vinci robotic system in head and neck surgery.

Intuitive Surgical Inc. (Sunnyvale, Ca, USA) extended the use of the da Vinci robot to head and neck surgery in 2005 following the previous use in urological, gynecological and cardiothoracic surgery. It then gained wide popularity throughout the globe. Our aim is to describe the da Vinci Robot System and discuss its applications in head and neck surgery. Continued refinements and applications in robotic surgery for otolaryngology will in time be possible as new robotic procedures are developed for endolaryngeal work.

Functional outcomes after transoral robotic surgery for squamous cell carcinoma of the oropharynx.

Over the past decade, the development of transoral robotic surgery (TORS) brought a new opportunity in the treatment of early T-stage oropharyngeal squamous cell carcinoma (OPSCC). The objective of this study is to review the functional outcomes after TORS. Indeed, dysphagia is among the most commonly cited functional impairments in OPSCC survivors treated by surgeries with an open approach or conventional radiotherapy. We performed a review of the literature and analysed functional outcomes after TORS. Althought the technique is very recent, early functional and oncologic outcome data are promising and the major studies analysing these parameters support that TORS is feasible and safe as well as oncologically and functionally efficacious.

Use of cidofovir in HPV patients with recurrent respiratory papillomatosis.

Recurrent respiratory papillomatosis is a viral-induced disease, associated with exophytic epithelial lesions affecting the upper airways. Problem of treatment is the high recurrence of papilloma growth after surgical removal; therefore, adjuvant therapy schemes have been established. We used cidofovir, 7.5 mg/ml, in adjuvant therapy in the past years. Out of 31 adult patients treated with the drug, 26 (83.9 %) are at the moment in complete response. 19 (73 % of pts with CR) of those 26 patients were cured with a number of injections between 1 and 4 (mean 2.5). We did not see any clinical manifestation of renal toxicity or neutropenia (superinfection) necessitating a blood test. Six patients presented dysplasia during the treatment with the drug, while six patients had dysplasia prior to cidofovir injection. Due to recurrent nature of the disease and the high number of mechanical and laser surgeries required we treated one tracheal stenosis, two scarred larynx, and two glottic synechiaes. There is still an ongoing discussion within the European Laryngological Society about the effectiveness and possible side effects of this drug. Results show promising long-term effects of adjuvant use of cidofovir, without any relevant side effects.

Endoscopic treatment of anterior glottic webs according to Lichtenberger technique and results on 18 patients.

Anterior glottic webs are most frequently acquired and result in a major vocal handicap. Many treatment modalities have been reported in the literature. None of them achieves perfect morphological or functional results. We present our series treated by an endoscopic technique based on CO(2) laser section of the web, mitomycin application and placement of a temporary silastic stent. We retrospectively reviewed the charts of 18 consecutive patients with anterior webs treated at our university hospital between 2003 and 2010. The endoscopic technique consisted of the section of the web with the CO(2) Acublade system, immediate application of mitomycin C and placement of a silastic stent. No tracheostomy was required. The stent was removed 3 weeks later. Patients had a vocal evaluation pre and postoperatively. It consisted of a video-stroboscopic examination, the global score of the Voice Handicap Index, the global and roughness scores of the perceptive voice evaluation according to Hirano, acoustic and aerodynamic parameters. Eighteen patients were included in the study with a mean age of 46 years (min. = 5, max. = 76). Twenty-two percent were women. All patients had postoperative speech therapy. The mean follow-up is 48.4 months (3-87 months). At the last follow-up, none of the patients had recurrence of the laryngeal web. The grade G of dysphonia significantly decreased from 2 to 1 (p = 0.035). CO(2) laser resection of anterior webs with mitomycin C application and placement of a silastic stent for 3 weeks induces a good morphological result with absence of web reformation but without substantial voice improvement observed in our series.

[Change of retinal oxygen saturation in healthy subjects and in early stages of diabetic retinopathy during breathing of 100% oxygen]. / Anderung der retinalen Sauerstoffsättigung bei Gesunden und in frühen Stadien der diabetischen Retinopathie nach Atmung von 100 % Sauerstoff.

BACKGROUND: Disturbances in the microcirculation are a source of retinal diabetic alterations. Comprehensive studies of blood flow parameters have been performed, but it is not known how ageing, duration of diabetes, blood sugar, glycolysed haemoglobin and elevated systemic blood pressure act in the early stages of diabetic retinopathy. MATERIAL AND METHODS: The arterial and venous oxygen saturation (aOS, vOS) were measured with a Jena Ophthalmo Spectrometer in 28 healthy subjects (NP) (30.3 +/- 13.1 years), 31 Type I diabetics (T I) (42.2 +/- 12.9 years), and in 25 Type II diabetics (T II) (58.9 +/- 6.9 years), suffering form mild or moderate non-proliferative diabetic retinopathy, before, during breathing of 100 % oxygen for 6 minutes, and after respiration of air during 10 minutes. RESULTS: Before oxygen breathing, the venous oxygen saturation in diabetics increased with age. During breathing of 100 % oxygen, the vOS increased considerably by 20 % in all groups. The arterio-venous difference of oxygen saturation was decreased with age in diabetics, but there was no dependence on age in normals. In Type II diabetics, the vOS before oxygen breathing was increased with HbA1c. There was also a positive correlation between vOS and blood pressure before oxygen breathing. CONCLUSION: Healthy subjects and diabetics in the early stages of diabetic retinopathy exhibit comparable changes of oxygen saturation during breathing of 100 % oxygen. Measurements of venous OS are most evident. First differences were detectable between diabetics and normals in the normalisation after oxygen respiration.