Balloon Eustachian Tuboplasty-A Feasible Double-Blinded Sham Surgery Randomized Clinical Trial Protocol to Study Efficacy.

INTRODUCTION: Balloon Eustachian tuboplasty (BET) is used to treat obstructive Eustachian tube dysfunction (OETD) and recurrent otitis media with effusion (OME). However, there are no indisputable evidence of its efficacy. Here, we present a multicenter, double-blinded, randomized, placebo-controlled trial (MDRCT) design to evaluate the efficacy of BET, and the results of a pilot trial with 3- and 12-months' follow-up. MATERIAL AND METHODS: This was a prospective MDRCT. For a pilot study, OETD (n = 10) and OME (n = 5) patients were recruited and followed. Detailed inclusion and exclusion criteria were used. Participants were randomized at beginning of the operation to active or sham surgery. All procedures were performed under local anesthesia. Controls were performed in double-blinded manner (both patient and physician), at 3 and 12 months after the procedure. RESULTS: Altogether, 20 ears were treated and followed for 12 months, including 14 active BETs and 6 sham surgeries. Both the active and sham surgery were performed under local anesthesia without problems or deviations from the protocol. There were no differences in the preoperative symptoms (ETDQ-7) or objective measures (tympanometry, Valsalva and Toynbee maneuvers, tubomanometry, Eustachian tube score) between active and sham surgery arms. During follow-up, we noticed largely similar reduction in subjective symptoms and improvement in Eustachian tube score both in active and sham surgery arms. CONCLUSIONS: The pilot study demonstrates that our MDRCT protocol is feasible, and that blinded RCTs are dearly needed to objectively measure the efficacy of BET. LEVEL OF EVIDENCE: 2 Laryngoscope, 134:1874-1881, 2024.

Computational fluid dynamics calculations in inferior turbinate surgery: a cohort study.

PURPOSE: To investigate how the results of nasal computational fluid dynamics (CFD) simulations change due to inferior turbinate surgery and how the results correlate with patient specific subjective assessment and volumetric results in the nasal cavities. METHODS: The steady inspiratory airflow of 25 patients was studied pre- and postoperatively with heat transfer from the mucous membrane by performing CFD calculations to patient-specific nasal cone beam computed tomography images. These results were then compared to the severity of the patients' nasal obstruction Visual Analogue Scale (VAS) and Glasgow Health Status Inventory assessments, and acoustic rhinometry measurements. RESULTS: Total wall shear forces decreased statistically significantly (p < 0.01) in the operated parts of the inferior turbinates. Patients' subjective nasal obstruction VAS assessment changes between the pre- and postoperative conditions correlated statistically significantly (p = 0.04) with the wall shear force results. CONCLUSION: Inferior turbinate surgery lead to decreased total wall shear force values postoperatively. Changes in subjective nasal obstruction VAS results against total wall shear force changes between the pre- and postoperative conditions were statistically significant. CFD data have a potential to be used for the evaluation of nasal airflow.

Computational fluid dynamics assessed changes of nasal airflow after inferior turbinate surgery.

OBJECTIVE: To demonstrate how Computational Fluid Dynamics (CFD) simulations can reveal important airflow changes in the nasal cavities due to surgical interventions. MATERIAL AND METHODS: The steady inspiratory airflow of eight patients was studied pre- and postoperatively with heat transfer from the mucous membrane by performing CFD calculations to patient specific cone beam computed tomography (CBCT) images. Eight patients with the largest distance from pre- and postoperative mean changes in inferior turbinate volumetry and Visual Analogue Scale (VAS) results were selected. RESULTS: Calculated CFD heat transfer results from the anterior parts of the inferior turbinates, where surgical interventions were performed, decreased significantly. The heat transfer results were in line with VAS changes. CONCLUSION: Surgical interventions reduced heat transfer in the operated parts of the inferior turbinates and were in line with VAS changes. CFD is an option in assessing patient well-being as a function of airflow parameters from mucous membrane with larger data sets. The limitations of the study were the small sample size and the preliminary nature of the study.

Three-Dimensional Measurements in Assessing the Results of Inferior Turbinate Surgery.

OBJECTIVES: Acoustic rhinometry is widely used in evaluating patients with nasal congestion, but it only has a partial correlation with patient symptoms. The use and focus of cone beam computed tomography (CBCT) scans are mainly on the paranasal sinuses and less on the nasal cavities. Therefore, information acquired from CBCT scans is not used to its full extent. In our present study, we have studied patients with enlarged inferior turbinates. Our aim was to investigate and compare the use of 3D volumetric measurements and cross-sectional area measurements taken from CBCT scans to results obtained from acoustic rhinometry. MATERIAL AND METHODS: In total, 25 patients with enlarged inferior turbinates were studied. CBCT scans were obtained preoperatively and at twelve months postoperatively. 3D volumetric and cross-sectional area measurements were compared to results from acoustic rhinometry, the visual analogue scale (VAS) and Glasgow Health Status Inventory (GHSI) questionnaires. RESULTS: A statistically significant change in 3D volume and cross-sectional area was measured in the anterior part of the inferior turbinate and surrounding air space after inferior turbinate surgery. VAS and GHSI results had mild correlations with the 3D volume and cross-sectional area measurements of the anterior part of the inferior turbinate. Acoustic rhinometry correlated with the air space 3D volume measurements in the anterior part. CONCLUSIONS: Fully utilized CBCT scans provide more comprehensive and accurate information. Furthermore, 3D analysis of the inferior turbinates provides valuable information and more precise measurements compared to acoustic rhinometry.

Factors Predictive of Outcome in Inferior Turbinate Surgery.

OBJECTIVES: The purpose of the study was to examine the various preoperative predictive factors of inferior turbinate surgery and to find possible factors that predict an optimal subjective response using 3 common surgical techniques-radiofrequency ablation (RFA), diode laser, and microdebrider-assisted inferior turbinoplasty (MAIT)-in a randomized, prospective study with a 1-year follow-up. METHODS: The patients filled a visual analogue scale (VAS) questionnaire regarding the severity of nasal obstruction prior to and 1 year after surgery. A VAS score improvement of 3 points or more was chosen as an optimal subjective response. Univariate and multivariate regressions were used to evaluate the effect of the predictive factors. In total, 80 patients attended a 1-year control visit. RESULTS: In the multivariate analysis, patients without anterior septal deviation had a statistically significantly higher odds ratio of a satisfactory subjective response compared to patients with anterior septal deviation (5.6; 95% CI: 1.4-23.1; P = .02). Patients treated with RFA had a statistically significantly higher odds ratio of an optimal subjective response compared to patients treated with MAIT (9.0; 95% CI: 1.5-54.2; P = .02). CONCLUSIONS: Anterior septal deviation seems to decrease the likelihood of an optimal subjective response to inferior turbinate surgery, which supports the consideration of concomitant septoplasty at least in clear cases to optimize the subjective response. Radiofrequency ablation had a significantly higher likelihood of an optimal subjective response compared to MAIT. Further investigations regarding the findings are needed.

The Long-term Effect of Inferior Turbinate Surgery Techniques on Nasal Obstruction and Quality of Life.

OBJECTIVE: The aim of the study was to compare the long-term effects of radiofrequency ablation (RFA), microdebrider-assisted inferior turbinoplasty (MAIT), and diode laser techniques on the severity of nasal obstruction and quality of life (QOL) in a 3-year follow-up. METHODS: The patients filled a Visual Analog Scale (VAS) regarding the severity of nasal obstruction and the Glasgow Health Status Inventory (GHSI) questionnaire preoperatively and during the control visits at 3 months and 3 years. Acoustic rhinometry was also performed. A total of 78 patients attended both control visits. RESULTS: All 3 techniques improved the VAS score for the severity of nasal obstruction and the GHSI total score significantly compared to the preoperative values at both 3 months and 3 years. Compared to the preoperative values, all 3 techniques increased the V2 to 5 cm values significantly at 3 months. After 3 years, compared to the preoperative values, the MAIT (P = .005) and diode laser (P < .001) still had a statistically significant volume increase in V2 to 5 cm, whereas the RFA (P = .06) did not achieve a statistically significant effect. CONCLUSION: The RFA, MAIT, and diode laser all improved both the patients' subjective sensation of the severity of nasal obstruction and QOL significantly. The response was sustained during the 3-year follow-up period with all 3 techniques. A weakening in the objective treatment response to RFA was found in the longer follow-up, but that did not cause a weakening of the patients' subjective treatment response.

The Effect of Inferior Turbinate Surgery on Quality of Life: A Randomized, Placebo-Controlled Study.

OBJECTIVE: The purpose of this prospective, randomized, single-blinded, placebo-controlled study was to investigate the effects of radiofrequency ablation (RFA), diode laser, and microdebrider-assisted inferior turbinoplasty (MAIT) techniques on patients' quality of life (QOL) and to compare the techniques with a placebo procedure. METHODS: A total of 98 consecutive patients with enlarged inferior turbinates due to persistent year-round rhinitis were randomized into placebo, RFA, diode laser, and MAIT groups at a ratio of 1:2:2:2. All the procedures were carried out under local anesthesia with the patients' eyes covered. Assessments were conducted prior to surgery and 3 months subsequent to the surgery. Quality of life was assessed with the Glasgow Health Status Inventory (GHSI). RESULTS: The GHSI total score increased statistically significantly in all the groups, including placebo. There were no significant differences in the GHSI total score change between RFA, diode laser, and MAIT groups. The MAIT procedure improved the GHSI total score significantly more than the placebo procedure (P = .04). CONCLUSION: All inferior turbinate surgery techniques lead to a significant improvement in the patients' QOL, and no significant differences were found between the techniques. The placebo treatment also improved the QOL significantly. Only the MAIT technique improved the QOL significantly more compared to placebo.

The effect of inferior turbinate surgery on nasal symptoms and inferior turbinate contractility.

OBJECTIVES: The aim of this study was to compare radiofrequency ablation (RFA), diode laser, and microdebrider-assisted inferior turbinoplasty (MAIT) in the treatment of chronic nasal obstruction in a one-year follow-up, and to pay special attention to the effect of the procedures on the contractility capacity of the inferior turbinates. METHODS: The patients filled a Visual Analogue Scale (VAS) questionnaire regarding nasal symptoms pre- and postoperatively. Saccharin transit time (STT) evaluation and acoustic rhinometry were also performed. A total of 77 patients attended the one-year control visit and had technically reliable acoustic rhinometry results. RESULTS: All the examined techniques decreased the VAS score for the severity of nasal obstruction statistically significantly. There was no deterioration found in the symptoms of crusting, nasal discharge, and sneezing, nor in mucociliary function in any of the groups. All the three techniques increased the non-decongested total V2-5 cm values and decreased the decongested total V2-5 cm values statistically significantly. The V2-5 cm change (%) values decreased statistically significantly in the RFA, diode laser, and the MAIT groups following the operations, the mean changes being -57 percentage points (pp), -53 pp, and -73 pp respectively. CONCLUSION: All three techniques decreased the severity of nasal obstruction significantly in the one-year follow-up. Although submucosal fibrosis seemed to increase, all the techniques increased the anterior nasal cavity volume significantly. Inferior turbinate contractility decreased to the normal level from the preoperative congested state following the surgery with every examined technique.

Assessment of PIV performance in validating CFD models from nasal cavity CBCT scans.

OBJECTIVE: The aim of our study was to investigate how well Particle Image Velocimetry (PIV) measurements could serve Computational Fluid Dynamics (CFD) model validation for nasal airflow. MATERIAL AND METHODS: For the PIV measurements, a silicone model of the nose based on cone beam computed tomography (CBCT) scans of a patient was made. Corresponding CFD calculations were conducted with laminar and two turbulent models (k-ω and k-ω SST). RESULTS: CFD and PIV results corresponded well in our study. Especially, the correspondence of CFD calculations between the laminar and turbulent models was found to be even stronger. When comparing CFD with PIV, we found that the results were most convergent in the wider parts of the nasal cavities. CONCLUSION: PIV measurements in realistically modelled nasal cavities succeed acceptably and CFD calculations produce corresponding results with PIV measurements. Greater model scaling is, however, necessary for better validations with PIV and comparisons of competing CFD models.

Pituitary apoplexy following endoscopic nasal surgery: A case report.

Pituitary apoplexy develops as a consequence of acute haemorrhage and/or infarction in a pre-existing pituitary adenoma. Typical symptoms include sudden onset headache, visual acuity/field defects, and ocular palsies. We report a male patient with a known pituitary macroadenoma who underwent a right-sided endoscopic nasal surgery. Preoperatively, thickening of sphenoid mucosa was seen in computed tomography and magnetic resonance imaging. The patient developed pituitary apoplexy postoperatively. The presented report indicates that in patients with a pituitary adenoma, nasal surgery - like any other kind of surgery - is a possible precipitating factor for pituitary apoplexy. Isolated thickening of sphenoid mucosa is associated with pituitary apoplexy. It may also precede an apoplectic event.

The effect of inferior turbinate surgery on ciliated epithelium: A randomized, blinded study.

OBJECTIVES/HYPOTHESIS: The aim of this study was to evaluate statistically the effects of radiofrequency ablation, diode laser, and microdebrider-assisted inferior turbinoplasty techniques on ciliated epithelium and mucociliary function. STUDY DESIGN: Prospective randomized study. METHODS: A total of 66 consecutively randomized adult patients with enlarged inferior turbinates underwent either a radiofrequency ablation, diode laser, or microdebrider-assisted inferior turbinoplasty procedure. Assessments were conducted prior to surgery and 3 months subsequent to the surgery. The effect on ciliated epithelium was evaluated using a score based on the blinded grading of the preoperative and postoperative scanning electron microscopy images of mucosal samples. The effect on mucociliary function, in turn, was evaluated using saccharin transit time measurement. RESULTS: The score of the number of cilia increased statistically significantly in the radiofrequency ablation (P = .03) and microdebrider-assisted inferior turbinoplasty (P = .04) groups, but not in the diode laser group. The score of the squamous metaplasia increased statistically significantly in the diode laser group (P = .002), but not in the other two groups. There were no significant changes found between the preoperative and postoperative saccharin transit time values in any of the treatment groups. CONCLUSIONS: Radiofrequency ablation and microdebrider-assisted inferior turbinoplasty are more mucosal preserving techniques than the diode laser, which was found to increase the amount of squamous metaplasia at the 3-month follow-up. The number of cilia seemed to even increase after radiofrequency ablation and microdebrider-assisted inferior turbinoplasty procedures, but not after diode laser. Nevertheless, the mucociliary transport was equally preserved in all three groups. LEVEL OF EVIDENCE: 1b Laryngoscope, 129:18-24, 2019.

A prospective, randomized, placebo-controlled study of inferior turbinate surgery.

OBJECTIVES/HYPOTHESIS: The purpose of this study was to compare radiofrequency ablation, diode laser, and microdebrider-assisted inferior turbinoplasty techniques in the treatment of chronic nasal obstruction caused by inferior turbinate enlargement, and to compare these techniques with a placebo procedure. STUDY DESIGN: Prospective, randomized, single-blinded, placebo-controlled study. METHODS: A total of 98 consecutive patients with enlarged inferior turbinates due to persistent year-round rhinitis were randomized into a placebo, radiofrequency ablation, diode laser, and microdebrider-assisted inferior turbinoplasty groups in a ratio of 1:2:2:2. All the procedures were carried out under local anesthesia with the patients' eyes covered. Assessments were conducted prior to surgery and 3 months subsequent to the surgery. RESULTS: The severity of nasal obstruction measured by visual analog scale score decreased statistically significantly in all the groups, including placebo. Radiofrequency ablation (P = .03), diode laser (P = .02), and microdebrider-assisted inferior turbinoplasty (P = .04) all decreased the symptom score of the severity of nasal obstruction statistically significantly more compared to the placebo procedure. CONCLUSIONS: The placebo effect had a large role in the overall improvement of the severity of nasal obstruction after the inferior turbinate surgery. However, all three techniques provided a statistically significant additional reduction of the severity of nasal obstruction compared to the placebo procedure. LEVEL OF EVIDENCE: 1b. Laryngoscope, 128:1997-2003, 2018.

The effect of inferior turbinate surgery on ear symptoms.

OBJECTIVE: The aim of this placebo-controlled study was to evaluate the effect of various inferior turbinate surgery techniques on Eustachian tube dysfunction-related symptoms. STUDY DESIGN: Outcomes were evaluated using the Eustachian Tube Dysfunction Questionnaire (ETDQ-7) and tympanometry results. METHODS: A total of 72 consecutively blinded and randomized adult patients with enlarged inferior turbinates due to persistent year-round rhinitis underwent either a radiofrequency ablation, diode laser, microdebrider-assisted inferior turbinoplasty, or sham surgery procedure. Assessments were conducted prior to surgery and 3 months subsequent to the surgery. RESULTS: In the evaluation of all patients, radiofrequency ablation, microdebrider-assisted inferior turbinoplasty, and sham surgery procedures decreased the ETDQ-7 total score significantly. In a three-way analysis of covariance, there were no significant differences in the results between sham surgery and any of the active treatment procedures. Allergic sensitization, sex, and age also had no effect on the results. There were no significant changes in the pre- and postoperative amounts of abnormal tympanometry curves or in the pre- and postoperative tympanometric peak pressure values in the actively treated patients or in the sham surgery group. CONCLUSION: The improvement of Eustachian tube dysfunction-related symptoms due to surgery of the anterior half of the inferior turbinate was found to be equal to placebo. The findings of this study do not support the use of reduction of the anterior half of the inferior turbinate as a sole procedure intended to treat the ear symptoms assessed by the ETDQ-7 questionnaire. LEVEL OF EVIDENCE: 1b. Laryngoscope, 128:568-572, 2018.

Eustachian Tube Dysfunction-Related Symptoms in Chronic Nasal Obstruction Caused by Inferior Turbinate Enlargement.

OBJECTIVE: The aim of this study was to evaluate the relationship between chronic nasal obstruction caused by inferior turbinate enlargement and Eustachian tube dysfunction-related symptoms using the Eustachian Tube Dysfunction Questionnaire (ETDQ-7) as an assessment method. METHODS: A total of 80 adults were enrolled. Group 1 comprised consecutive patients with enlarged inferior turbinates and group 2 comprised healthy controls. The ETDQ-7 scores and tympanometry results of both groups were analyzed and compared. RESULTS: The median total scores of the ETDQ-7 in groups 1 and 2 were 1.9 (interquartile range, 1.4-2.8) and 1.1 (interquartile range, 1.0-1.7), respectively ( P < .001). There was no significant difference in the abnormal tympanometry results between the groups. There was no significant difference in the ETDQ-7 total score between the patients with allergic sensitization and other patients in group 1. CONCLUSIONS: Patients with inferior turbinate enlargement have more symptoms related to Eustachian tube dysfunction than healthy controls. Most patients with Eustachian tube dysfunction had normal tympanometry and normal otoscopy, which indicates a baro-challenge-induced Eustachian tube dysfunction. Whether the patient has allergic sensitization or not does not seem to cause a difference in symptoms related to Eustachian tube dysfunction.

Significance of imaging in the diagnosis of olfactory disorder.

The aim of this retrospective analysis was to examine olfactory disorders among the patients in the Ear, Nose, and Throat Clinic of Tampere University Hospital, Finland, from 2001 to 2011, and to evaluate the necessity of imaging in the examination of patients with olfactory disorders. Charts of 143 consecutive patients with a primary olfactory disorder were examined, and 69 patients who had undergone the necessary testing were included in the study. The most common causes of olfactory disorder were upper respiratory infection (23%), chronic rhinosinusitis (19%), head trauma (17%), and allergic or nonallergic rhinitis (6%). In 25% of the patients, no obvious cause for the symptoms was found. Computed tomography (CT) scans were normal in 37 of 52 (71%) patients and magnetic resonance imaging was normal in 21 of 25 (84%) patients. No intracranial or intranasal tumors were found in the overall cohort. Of the patients with additional symptoms (facial pain, headache, nasal discharge, or stuffiness), 58% had chronic rhinosinusitis. Of the patients with no additional symptoms or signs associated with chronic rhinosinusitis on clinical evaluation, only 2% had chronic rhinosinusitis on imaging. Only the detection of chronic rhinosinusitis and head trauma had clinical value in the determination of the etiology. A sinonasal CT scan should be considered in patients who have at least one symptom associated with sinusitis in addition to an olfactory disorder to confirm the etiology and to find those patients who may benefit from medical therapy or surgical treatment.

Facial subcutaneous emphysema after tonsillectomy.

BACKGROUND: Tonsillectomy is a commonly performed and relatively safe surgical procedure. However, it can potentially be associated with several complications. We report a case of facial subcutaneous emphysema that occurred after elective tonsillectomy. CASE: Tonsillectomy was performed on a patient with a history of frequent tonsillitis. After surgery, the patient developed facial subcutaneous emphysema that resolved within a few days without any further complications. CONCLUSION: Subcutaneous emphysema is a rare complication of tonsillectomy. Tonsil should be removed along the tonsilar capsule. If its removal causes a deeper than usual mucosal tear up to the level of the muscles, then air might potentially pass through the pharyngeal wall to the parapharyngeal, retropharyngeal and prevertebral spaces.