Off-label drugs in otolaryngological practice against the background of legal conditions of Polish legislation.

<b><br>Introduction:</b> 'Off-label drug use' refers to the administration of drugs for unapproved indications or age groups, a different dosage or other form of administration. Considering the legal issues, there clearly exists a need to implement rules that would regulate the use of pharmaceuticals outside the scope of a marketing authorisation. The brevity and diversity of Polish laws in the field of health care leads to many interpretative doubts associated with particular legal acts.</br> <b><br>Aim:</b> We aimed to present clinical examples from everyday practice of off-label drug use from the medical and legal perspectives, and to support it with relevant legal acts.</br> <b><br>Material and method:</b> Off-label drug use in various otolaryngology subspecialties - otology (mesna), laryngology (bevacizumab, cidofovir and botulinum toxin) and head and neck surgery (botulinum toxin) - are presented and discussed in detail.</br> <b><br>Results:</b> Fourteen Polish legal acts regarding off-label drug use and 4 from EU legislation are commented on. The algorithm of cascade of decision-making processes in off-label drug use is shown.</br> <b><br>Conclusions:</b> Off-label use of medicinal products is not prohibited in Poland or the EU; nevertheless, it is undeniable that the unclear legal situation regarding the use of medicinal products for nonregistered indications creates difficulties. To minimise a doctor's liability risk, obtaining the informed consent from the patient for such treatment is advisable.</br>.

Algorithms of follow-up in patients with head and neck cancer in relation to primary location and advancement. Consensus of Polish ENT Society Board and Head Neck Experts.

Summary: The algorithm of follow-up in patients with head and neck cancer (HNC) has been prepared by a board of Polish Head Neck and Oncology Experts. The aim of this research is to focus on the specificity of HNC monitoring, to review the current trends in follow-up, and to adapt the evidence-based medicine international standards to the capabilities of the local healthcare service. Materials and methods: The first methodological step was to categorize HNCs according to the estimated risk of failure after the adequate first-line treatment and according to the possibility of effective salvage treatment, resulting in improved overall survival. The final method used in this work was to prepare an authors' original monitoring algorithm for HNC groups with a high, moderate, and low risk of recurrence in combination with a high or low probability of using an effective salvage. Results: Four categories were established: Ia. low risk of recurrence + effective organ preservation feasible; Ib. low risk of recurrence + effective salvage feasible; II. moderate risk of recurrence + effective salvage feasible; III. high risk of recurrence + effective salvage feasible; and IV. high risk of recurrence + no effective salvage feasible. Follow-up visit consisting of 1. ENT examination + neck ultrasound, 2. imaging HN tests, 3. chest imaging, 4. blood tests, and 5. rehabilitation (speech and swallowing) was scheduled with a very different frequency, at the proposed monthly intervals, tailored to the needs of the group. The number of visits for individual groups varies from 1 to 8 in the first 2 years and from 1 to 17 in the entire 5-year monitoring period. Group IV has not been included in regular follow-up, visits on own initiative of the patient if symptomatic, or supportive care needs, having in mind that third-line therapy and immune checkpoint inhibitors are available. Conclusion: Universal monitoring algorithm for HNC four groups with a high, moderate, and low risk of recurrence after the adequate treatment in combination with a high or low probability of using an effective salvage is an innovative approach to redeploying system resources and ensuring maximum benefit for patients with HNC.

Immunohistochemical Identification and Assessment of the Location of Immunoproteasome Subunits LMP2 and LMP7 in Acquired Cholesteatoma.

Cholesteatoma, accompanied by chronic inflammatory response, is characterized by invasive growth and osteolytic activity. As specific proteasome isoforms, the immunoproteasomes serve as an important modulator of inflammatory responses. The aim of the present study was to determine the biological activity of cholesteatoma through the analysis of the expression and localization of immunoproteasome subunits of low molecule weight protein (LMP) 2 and LMP7. Cholesteatoma specimens were obtained from 15 adults who underwent ear surgery due to acquired attic cholesteatoma. Normal skin specimens were taken from retro-auricular skin incisions from the same patients. The specimens were stained with anti-LMP7 antibody, using immunohistochemistry techniques based on the binding of biotinylated secondary antibody with the enzyme-labeled streptavidin and the Envision FLEX system. In all specimens of cholesteatoma, the immunohistochemical reaction with the antibody against the LMP2 was positive, in both the cytoplasm of the cholesteatoma matrix and the perimatrix. A negative reaction with anti-LMP2 was observed in the cytoplasm and nuclei of control skin cells. A positive nuclear and cytoplasmic immunohistochemical reaction with anti-LMP7 has been demonstrated in numerous cells, in both the matrix and perimatrix of cholesteatoma. We present evidence of the presence of expressions of LMP2 and LMP7 within cholesteatoma tissue. Our results might bring new information concerning immunoproteasome-dependent pathophysiologic mechanisms in cholesteatoma.

Multidimentional assessment of voice quality in patients with laryngopharyngeal reflux disease.

<b><br>Introduction:</b> Gastroesophageal Reflux Disease (GERD) is a common disorder in world population. As a result of the regurgitation of acid content from the stomach to laryngopharynx and larynx, secondary damage of laryngeal mucosa occur, which is highly sensitive to hydrochloric acid, and morphological changes are observed. Symptomatology of laryngopharyngeal reflux is varied which makes differential diagnosis difficult.</br> <b><br>Aim:</b> The aim of the study was the assessment of voice quality, morphological changes in larynx as well as etiology of Laryngopharyngeal Reflux Disease.</br> <b><br>Material and method:</b> The severity of dysphonia was classified using perceptual and acoustic methods as well as RSI. Morphological control was performed using HSDI technique and RFS. Etiological factors were examined basing on barofunction of upper esophageal sphincter and 24-hour pH-metry of air exhaled expressed in Ryan score.</br> <b><br>Results:</b> In the majority of patients with Laryngopharyngeal Reflux, dysphonia was recognized, intensified especially in women (G3R2B0A0S3), which was confirmed in Yanagihara classification (type III) and parameters of acoustic analysis. Voice disorders were the most frequently the result of edema and congestion of interarytenoid area, aytenoids and vocal folds. Those symptoms were caused by the decrease of upper esophageal sphincter tension and acidity of exhaled air which was confirmed in 24-hour pHmetry.</br> <b><br>Conclusions:</b> It is important to educate physicians and patients about the possibilty of negative impact of reflux disease on the occurrence of voice quality disorders. Current diagnostic methods for dysphonia guarantee accurate recognition and therapeutic success improving the prognoses of patients with Laryngopharyngeal Reflux.</br>.

Long-term outcomes of pharyngoplasty for Obstructive Sleep Apnea Syndrome.

Introduction: Pharyngoplasty techniques for the treatment of obstructive sleep apnea syndrome (OSAS) have evolved, which improved the understanding of the anatomy, patient selection, and adoption of functional approaches. Aim: To analyze long-term results of pharyngoplasty in OSAS patients. Material and methods: Between 2007 and 2021, a total of 234 adult patients with OSAS who had previously failed positive airway pressure (PAP) therapy underwent sleep surgery. Of this group, 75 patients met the criteria of a minimum 5-year follow-up. To date, 25 patients completed the follow-up study protocol, including the medical history, visual analog scale (VAS) for snoring loudness, body mass index (BMI), endoscopy of the upper airways, type III sleep study, and standardized questionnaires including Epworth Sleepiness Scale (ESS) and EQ-5D-5L Euro - Quality of Life Questionnaire. Results: The average period of follow-up was 96.80 ± 30.20 months. The mean age of participants was 54.6 ± 14.02 and the mean BMI 30.28 ± 2.74. Patients underwent uvulopalatopharyngoplasty (n = 21) and expansion sphincterpharyngoplasty (n = 4) between 2008-2015. A long-term improvement in sleep parameters was observed for the mean AHI (29.84 ± 20.06before and 19.45 ± 18.53 after surgery, p = 0.0294), and the median VAS (8.13 before and 3.78 after surgery), mean oxygen saturation during sleep 94,5% (IQR 93.0-95.25), and the median ESS score was 6.17 ± 4.57. The majority of patients reported subjective long-term improvement in sleep quality and a reduction of snoring. Conclusions: In OSAS patients who failed PAP therapy, pharyngoplasty may provide a long-term improvement in upper airway obstruction during sleep.

Adjuvant radiotherapy in parotid gland pleomorphic adenoma - recommendations.

<b>Introduction:</b> Standard treatment for pleomorhic adenoma (PA) of the parotid gland is complete surgical excision. Radiotherapy (RT) as a primary treatment method is controversial and generally is not applied. However, RT might be considered as an adjuvant therapy in some selected cases. </br></br> <b>Aim:</b> The aim of this work was to define recommendations for RT in patients with parotid gland PA after primary surgical treatment.</br></br> <b>Material and methods:</b> Based on the results currently published in the literature and the authors' own experiences from leading Polish laryngological and oncological clinical centers dealing with the treatment of salivary gland tumors, the indications for irradia- tion and its methods in patients with PA of the salivary glands were discussed. </br></br> <b>Results and discussion:</b> Authors recommend personalized treatment based on multidisciplinary panel decisions in each patient. Adjuvant RT should be considered in cases of suboptimal resection of primary PA (close margin, intraoperative tumor spillage, risk of recurrence based on clinical factors and histological features), and in cases of PA recurrence. Doses/ fractions and techniques of irradiation are recommended depending on the clinical extension of the primary or recurrent tumor. </br></br> <b> Conclusions:</b> Adjuvant RT in PA treatment should be a result of a personalized multidisciplinary decision after considering all possible risks of irradiation consequences. Recommendations for this treatment should be taken into consideration.

Endoscopic transconjunctival optic nerve sheath fenestration for progressive idiopathic visual field deficit: a case report.

Intra-orbital optic nerve sheath fenestration (ONSF) is an effective option in patients with progressive vision loss due to idiopathic intracranial hypertension. Most proposed techniques involve surgical trauma and require disinsertion of the medial rectus muscle; thus, less invasive surgical procedures are needed. Here, a feasible and effective technique of endoscopic intra-orbital ONSF through a conjunctival incision is presented, in a patient with a progressively compromised visual field, papilloedema, and distended subarachnoid space around the optic nerves. The retrobulbar segment of the optic nerve was exposed for incision, avoiding manipulation of the lateral orbital rim bones and irritation of the ciliary microvessels and nerves. The patient regained the entire visual field. ONSF was safely and effectively performed endoscopically through a narrow corridor gained by brushing away the orbital fat with minimal traction on the medial rectus muscle. The small postoperative wound was associated with faster and easier convalescence, and less tissue trauma versus conventional open approaches.

Training in intraoperative neuromonitoring of recurrent laryngeal nerves reduces the risk of their injury during thyroid surgery.

INTRODUCTION: Even though incidence of recurrent laryngeal nerve palsy (RLNP) is low, it affects importantly the quality of life of patients and remains one of main medicolegal litigation problems in surgery. Intraoperative neuromonitoring (IONM) has become widely accepted tool helping in recurrent laryngeal nerve identification, however no clear association of IONM with RLNP rate has been demonstrated. The aim of our study was to assess whether training in IONM influences rates of RNLP after thyroid surgery as an independent factor. MATERIAL AND METHODS: We analysed retrospectively 1235 patients who underwent thyroidectomy at the 1st Department of General and Endocrine Surgery, Medical University of Bialystok. Possible risk factors for RLNP were evaluated: application or not of IONM, the extent of surgery or thyroid pathology in correlation with surgeons' experience in IONM (trained or untrained). RESULTS: There were 2351 nerves at risk (NAR) and 39 RNLP were diagnosed after thyroid surgery (1.66%). Surgeons trained in IONM performed 52.2% of all operations (1200 NAR) with 7 RLNP (0.58%), whereas not-trained had 32 RLNP for 1151 NAR (2.8%; p < 0.001). After 182 thyroidectomies (357 NAR) guided by IONM (14.7%) 3 RLNP were observed (0.84%) vs. 36 palsies per 1994 NAR without IONM (1.81%; p = 0.189). The highest danger of RLNP was reported after reoperations and the lowest after subtotal thyroidectomies. We found no association between thyroid pathology and RLNP rate. CONCLUSIONS: According to our study training in IONM decreases chances of RLNP especially during total or near total thyroidectomy.

Transnasal endoscopic skull base surgery in the COVID-19 era: Recommendations for increasing the safety of the method.

Transnasal endoscopic skull base surgery (eSBS) has been adopted in recent years, in great part to replace the extended procedures required by external approaches. Though sometimes perceived as "minimally invasive", eSBS still necessitates extensive manipulations within the nose/paranasal sinuses. Furthermore, exposure of susceptible cerebral structures to light and heat emanated by the telescope should be considered to comprehensively evaluate the safety of the method. While the number of studies specifically targeting eSBS safety still remains scarce, the problem has recently expanded with the SARS-CoV-2 pandemic, which also has implications for the safety of the surgical personnel. It must be stressed that eSBS may directly expose the surgeon to potentially high volumes of virus-contaminated aerosol. Thus, the anxiety of both the patient and the surgeon must be taken into account. Consequently, safety requirements must follow the highest standards. This paper summarizes current knowledge on SARS-CoV-2 biology and the peculiarities of human immunology in respect of the host-virus relationship, taking into account the latest information concerning the SARS-CoV-2 worrisome affinity for the nervous system. Based on this information, a workflow proposal is offered for consideration. This could be useful not only for the duration of the pandemic, but also during the unpredictable timeline involving our coexistence with the virus. Recommendations include technical modifications to the operating theatre, personal protective equipment, standards of testing for SARS-CoV-2 infection, prophylactic pretreatment with interferon, anti-IL6 treatment and, last but not least, psychological support for the patient.

Assessment of Lacrimal Duct Patency in Patients Undergoing Endoscopic Medial Maxillectomy.

PURPOSE: The risk of epiphora after medial maxillectomy with lacrimal duct transection is difficult to assess. The data available in the literature are inconclusive due to various operating techniques used by the authors of medical publications, different additional procedures aimed at improving tear drainage after maxillectomy, and a variety of lacrimal duct patency assessment techniques. The aim of our work was to assess the anatomical and functional patency of lacrimal ducts after medial maxillectomy without performing additional procedures to improve tear drainage as well as comparison of the results obtained with different assessment tests. MATERIALS AND METHODS: 21 patients who underwent medial maxillectomy in the years 2016-2019 were assessed for discomfort and epiphora based on patients' own reports and basic clinical examination, lacrimal duct rinse test, the Munk score, and a modified endoscopic Jones I test. RESULTS: Gradually increasing the sensitivity of the assessment method resulted in an increase in the number of patients with potential tear drainage disorders, starting from 0% in the rinsing test, 4.8% self-reported tearing complaints, 14.3% Munk score, and 19% modified endoscopic Jones I test. CONCLUSIONS: The study results revealed that a small fraction of patients tend to report epiphora as a consequence of medial maxillectomy themselves. Subtle functional disorders, which are not particularly bothersome to patients, are more common. More sensitive lacrimal duct patency tests reveal more cases of tear drainage disorders. The results of studies assessing the incidence of epiphora after medial maxillectomy appear to depend on the type of test used.

Expression of LIGHT/TNFSF14 and Its Receptors, HVEM and LTßR, Correlates with the Severity of Fibrosis in Lacrimal Sacs from Patients with Lacrimal Duct Obstruction.

INTRODUCTION: Fibrosis is one of the factors contributing to the development of primary acquired lacrimal duct obstruction (LDO). LIGHT (homologous to lymphotoxins, exhibiting inducible expression and competing with herpes simplex virus glycoprotein D for herpes virus entry mediator [HVEM]), a receptor expressed by T lymphocytes, has recently emerged as a new regulator of connective tissue remodeling and fibrotic response. The purpose of this study was to evaluate the role of LIGHT in the pathogenesis of LDO through: (1) assessment of expression of LIGHT and its two receptors, HVEM and LTßR (lymphotoxin ß receptor), and (2) investigation of potential relationships between expression of LIGHT and its receptors and clinical and histopathologic features. METHODS: Lacrimal sacs of 30 patients undergoing endoscopic dacryocystorhinostomy because of LDO were assessed intraoperatively and histopathologically with respect to inflammation and fibrosis. Expression of LIGHT, HVEM and LTßR was assessed by immunohistochemistry using specific antibodies and evaluated semiquantitatively using a four-grade scoring system. RESULTS: All investigated molecules, LIGHT/TNFSF14, HVEM and LTßR, were expressed in biopsies from all patients. The most prominent expression was seen within inflammatory infiltrates. Expression of LIGH, HVEM and LTßR correlated significantly with the intensity of fibrosis and duration of the disease. In multivariate analysis only LIGHT showed a significant relationship with fibrosis (ß coefficient = 0.759, p = 0.02). There was no significant correlation between expression of any molecule and other demographic or clinical features. CONCLUSION: We assume that LIGHT along with its receptors may be a factor contributing to fibrosis and synechiae formation in the lacrimal sac. This assumption needs to be proven in a future study in a group of patients who fail to improve after the first operation.

Brain tissue oxygenation during transnasal endoscopic skull base procedures.

PURPOSE: We aimed to study brain tissue oxygenation during the period of controlled reduction of arterial blood pressure - a maneuver often used in extended endoscopic skull base surgery for bloodless operative field. METHODS: Intracranial pressure, arterial blood pressure and the resultant cerebral perfusion pressure were measured during extended endoscopic skull base surgery in 5 patients with diagnosed tumors of the skull base and arterial hypertension. Simultaneously, in those patients, we measured partial pressure of oxygen in the brain parenchyma (PbtO2). RESULTS: Values of PbtO2 lower than 15 mm Hg (risk of brain ischemia) were observed in 3 patients for periods of 40 min, 110 min and 123 min, respectively. In 2 of these patients, no hypotension (mean arterial pressure <65 mm Hg) was necessary for bloodless operative field. Another 2 patients had PbtO2 above 30 mm Hg at the time when their mean arterial pressure was below 65 mm Hg. The time course of PbtO2 followed that of cerebral perfusion pressure with a time lag of 40-60 s in all patients. CONCLUSION: Moderate reduction of arterial pressure, often used to obtain bloodless operative field during extended endoscopic skull base surgery, may in patients with the medical history of arterial hypertension be associated with critically low values of partial oxygen pressure in brain tissue.

Histological evaluation of soft palate tissues in patients with sleep disordered breathing.

Introduction Sleep is a physiological state essential for proper functioning of the body. One of the reasons for sleep disorders is obstructive sleep apnea syndrome (OSAS). AIM: The aim of this research is histological evaluation of the mucous membrane of the soft palate in patients affected by various forms of OSAS. MATERIAL AND METHOD: The studied group consisted of patients with sleep-related breathing disorder in the form of primary snoring or OSAS. People with chronic tonsillitis, without a history of sleep-related breathing disorders, were included in the comparative group. Fragments of the mucous membrane of the uvula (study group) and the glossopalatine arch (comparative group) were taken for histological examination during surgery. Using histological, histochemical and immunohistochemical methods, we assessed the presence and severity of inflammation (CD3, CD20, CD68), the structure of nerve fibers (S-100) and the size of blood vessels (CD34) in the examined tissue. RESULTS: Patients with OSAS developed a local inflammatory process in the oropharyngeal tissues (stronger expression of CD3, CD20, CD68 in people with OSAS). The exacerbation of the immunohistochemical reaction with CD3 correlated with the phase of OSAS. We found a higher degree of fibrosis and a higher expression of CD34 and S-100 receptors in subjects with OSAS compared to snoring patients and patients from the comparative group. DISCUSSION: Due to chronic tissue vibration, snoring most likely leads to damage to the nerve fibers in the soft palate, which can intensify episodes of shallow breathing during sleep and increase the occurrences of apnea.

Cysteinyl leukotriene 1 receptor expression in nasal polyps.

Cysteinyl leukotrienes (CysLTs) have been implicated in the pathogenesis of chronic rhinosinusitis (CRS). This study was undertaken to better understand the role of CysLTs in the development of CRS through 1). assessment of the pattern of expression of CysLT1 receptor in nasal polyps from patients with CRS and 2). correlation of expression of CysLT1 receptor with clinical features. Expression of CysLT1 receptor was evaluated immunohistochemically in nasal polyps from 20 patients with CRS and nasal mucosa from 10 control subject undergoing plastic surgery of the nose. Patients with CRS showed significantly higher expression of CysLT1 receptor as compared with the control group (p<0.05). The expression of CysLT1 receptor in sub-epithelial inflammatory infiltrates tended to be higher in patients with CRS and allergy as compared with patients with CRS but without allergy (p=0.07). In particular, the expression of CysLT1 receptor in sub-epithelial inflammatory infiltrates was significantly greater in 3 patients with CRS and drug allergy as compared with patients with CRS but without drug allergy (p=0.03). Increased expression of CysLT1 receptor in inflamed mucosa of nasal polyps in patients with allergy might suggest particular role of CysLTs in the pathogenesis of nasal polyps in this group of patients.

Haemangiopericytoma-like tumor of the nasal cavity treated by endoscopy - a case report.

Haemangiopericytoma (HPC) is an uncommon, vascular tumor derived from Zimmerman pericytes surrounding blood vessels. HPC constitute around 1% of all tumors of vascular origin and may appear anywhere, 5% of them can be situated in nasal cavity. Tumor location within the head and neck predispose to its benign character and improves prognosis. This case report presents the case of 33-year-old patient with haemangiopericytoma-like tumor of the nasal cavity, presented symptoms of impaired nasal breathing and recurrent epistaxis. Tumor was excised with 0 degree endoscope. The follow-up recurrence-free period was 2 year 6 months and shows this is effective way of treatment. Described in the literature late recurrences and metastases reminds that regular, life-long observation is mandatory.

Neurobiochemical markers of brain ischemia in patients subjected to endoscopic skull base surgery under controlled hypotension.

BACKGROUND: Previous studies showed that moderate hypotension used to control bleeding during extensive endoscopic skull base procedures may cause a decrease in blood flow velocity (BFV) in the middle cerebral artery (MCA). We assessed possible metabolic consequences of reduction of arterial pressure applied in endoscopic skull base operations. METHODS: The serum concentrations of neuron specific enolase (NSE) and S-100 protein were measured in 15 patients operated on with reduced hemodynamic parameters (hypotensive group) and in 10 individuals operated on under normotensive conditions (normotensive group). Concentrations of NSE and S-100 were assessed preoperatively, as well as 24 h and 48 h postsurgery. Blood flow velocity in the MCA was evaluated with transcranial color Doppler sonography. RESULTS: An increase in NSE concentration was demonstrated in 5 out of 6 patients from the hypotensive group in whom BFV in the MCA dropped below normal reference range during surgery. An association between both phenomena was confirmed on statistical analysis. Neither the rise of S-100 concentration nor postoperative neurological deficits were detected in any of the studied individuals. CONCLUSIONS: Controlled hypotension during skull base procedures can result in postoperative increase in NSE serum concentration, a phenomenon suggestive for a degree of brain ischemia. Noticeably, the rise of NSE level occurs in subjects in whom BFV in the MCA decreased below normal reference limit during the surgery. Although neither S-100 protein level increase nor neurological deficits were detected postoperatively, further studies of the safety of hypotension applied during endoscopic skull base operations are warranted.

Quality of life and hearing after cochlear implant placement in patients over 60 years of age.

OBJECTIVE: Multicenter evaluation of the quality of life and quality of hearing after Nucleus® cochlear implant placement in patients over 60 years of age. REFERENCE AND METHOD: Evaluation was performed in patients receiving cochlear implants after the age of 60 years as a part of the Cochlear-Implanted Recipient Observational Study (Cochlear-IROS). This study is a prospective, international and long-term assessment which enables observation of recipients for up to three years after implantation. Data regarding subjective evaluation of the quality of life and quality of hearing were gathered before the first switch-on of the sound processor and one year afterwards. Standardized questionnaires were used in this evaluation, including Health Utility Index (HUI mk. III) and Speech, Spatial and Qualities of Hearing (SSQ) Scale. Data were also gathered regarding the aetiology of hearing loss, hearing aid usage, tinnitus and vertigo, as well as on the telephone usage and the professional status of recipients. RESULTS: Included in the evaluation, were 20 subjects who were over 60 years old at the moment of the cochlear implant surgery. The study group consisted of 12 men and 8 female patients. The average age of CI recipients at the moment of implantation was 67.8 years (min. 60, max. 80 years). The SSQ questionnaire outcomes regarding self-assessment in the field of ability to hear in everyday situations one year after the surgery indicate that speech understanding increased by 180%, spatial hearing increased by 135 % and quality of hearing increased by 98%. Overall quality of life before the first sound processor switch-on as assessed using the HUI questionnaire was at the level of 0.38 (on 0-1 scale, where 0 equals death, and 1 equals full health). One year after the implantation, this assessment increased by 33% (up to 0.5 on the scale). CONCLUSION: The effectiveness of the cochlear implantation in patients with severe hearing loss after 60 years of age with respect to the quality of life and hearing was confirmed. Statistically significant improvement was demonstrated in the self-assessment of patients in relation to the speech understanding, spatial hearing and quality of hearing, as well as quality of life.

Evaluation of fully biodegradable nasal packings in functional endoscopic sinus surgery ­ a multi-centre study.

THE AIM: This work was to compare an innovative solution, i.e. a fully biodegradable nasal packing Nasopore®, with a traditional one, in the aftercare of patients subjected to functional endoscopic sinus surgery. MATERIAL AND METHOD: Prospective, blinded study with sequential enrollment conducted at three study centres. One of the investigators evaluated during surgery the level of bleeding in each of the nasal cavities and at the end of surgery he applied the test packing, the biodegradable dressing Nasopore®, to one randomly chosen nasal cavity, and a control packing to the other one. The other investigator removed during aftercare the control packing and conducted the follow-up. During the control visits (24-48 hours, 10 and 30 days post-op.) the subjects evaluated their headache, pain in the nose, pressure in the forehead as well as their nasal obstruction. RESULTS: A total of 39 women and 44 men at the age of 47 years on average (min. 19, max. 82) were qualified for the study. The largest differences between different types of nasal dressings were observed with regard to reduction of nasal obstruction in the fist 10 days after surgery (P<0.005). In relation to the pain in the area of the head and nose as well the pressure in the forehead on every visit, better outcomes were observed for the test dressing. Statistical difference (P<0.05) was observed on the fist follow-up visit for the headache and pressure in the forehead as well as on the fist and second visit for the pain in the nose. CONCLUSION: The fully biodegradable nasal dressing Nasopore® may constitute significant improvement and facilitation of aftercare in functional endoscopic sinus surgery while increasing the patients' satisfaction and lowering the postoperative discomfort.

The transmaxillary endoscopic approach to the inferior part of the orbit: how I do it.

BACKGROUND: Transmaxillary endoscopic approach to the inferior part of the orbit was demonstrated on cadaveric preparations; however, its clinical application has not been reported. We describe a clinically useful technique of the transmaxillary approach to the lower orbit. METHODS: A four-hand technique is essential for extensive preparation within the orbit; therefore, the tools have to be introduced into the maxillary sinus through two ports: either through the canine fossa and antrostomy or through antrostomy using the bi-nostril transseptal approach. CONCLUSION: Intraorbital pathologies located in the inferior retrobulbar space can be successfully operated on using the transmaxillary endoscopic approach.