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OTO Open 2021To determine the safety and efficacy of temperature-controlled radiofrequency (RF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic...
OBJECTIVE
To determine the safety and efficacy of temperature-controlled radiofrequency (RF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis.
STUDY DESIGN
A multicenter, prospective, single-blinded, randomized controlled trial, in which the control arm underwent a sham procedure.
SETTING
Sixteen otolaryngology centers.
METHODS
Patients with 24-hour reflective Total Nasal Symptom Score (rTNSS) ≥6, including moderate to severe rhinorrhea and mild to severe congestion, were randomized 2:1 to active treatment of the posterior nasal nerve area with a temperature-controlled RF device or a sham procedure, with no RF energy delivery. The stylus was applied bilaterally to nonoverlapping areas of the posterior middle meatus and posterior inferior turbinate in each nostril in the region of the PNN. The primary endpoint was responder rate at 3 months, where a response was defined as ≥30% improvement (decrease) in rTNSS from baseline.
RESULTS
Patients had a mean baseline rTNSS of 8.3 (95% CI, 7.9-8.7) and 8.2 (95% CI, 7.6-8.8) ( = .797) in the active treatment (n = 77) and sham control (n = 39) arms, respectively. At 3 months, responder rate was significantly higher in the active treatment arm: 67.5% (95% CI, 55.9%-77.8%) vs 41.0% (95% CI, 25.6%-57.9%) ( = .009). The active treatment arm had a significantly greater decrease in rTNSS (mean, -3.6 [95% CI, -4.2 to -3.0] vs -2.2 [95% CI, -3.2 to -1.3]) ( = .013). Three adverse events related to the device/procedure were reported, and all resolved.
CONCLUSION
This randomized controlled trial showed temperature-controlled neurolysis of the PNN area is free from significant adverse events and superior to a sham procedure in decreasing the symptom burden of chronic rhinitis.
PubMed: 34527852
DOI: 10.1177/2473974X211041124 -
Indian Journal of Otolaryngology and... Apr 2023Spontaneous or post-traumatic CSF (cerebrospinal-fluid) rhinorrhea occurs when there is a skull-base defect. In our study, we tried endoscopic approach, exclusively as...
Spontaneous or post-traumatic CSF (cerebrospinal-fluid) rhinorrhea occurs when there is a skull-base defect. In our study, we tried endoscopic approach, exclusively as surgical modality. To study feasibility of trans-nasal endoscopic approach for repair of skull-base defects and success rates at each anatomical subsite, with complications. Patients, who underwent endoscopic repair of CSF rhinorrhea between 2016 and 2019 were recruited into study. Details of investigative work-up, aetiology, surgery done, site of leak, number of surgical procedures done, post-operative complications and their management, success rate for each anatomical sub-site, was retrieved retrospectively and analyzed. All patients were initially managed with conservative measures before taking up for surgery. Eighteen-patients (male-11, female-7, mean age-40.3 years) with CSF rhinorrhea {spontaneous-5(27.7%), traumatic-13(62.3%)} were found. Sites of leak were cribriform-plate (CP), fovea-ethmoidalis (FE) and posterior-table of frontal-sinus (FS) in 8(44.4%), 5(27.7%) and 5(27.7%) respectively. Twelve (66.6%) patients had no postoperative complications. No patients with defects in CP had post-operative complication. Two (11.1%) patients with FS defect had meningitis, one (5.5%) patient with FS defect developed pneumocephalus. One (5.5%) patient developed frontal sinusitis at end of 4-months. Two (11.1%) patients, each with defects in FE and FS needed a revision repair on postoperative day 0 and 90-till date, none of the patients have any delayed procedure related complications or recurrences. Endoscopic repair of CSF leaks is the norm of the current day due to its minimally invasive nature. However, endoscopic repair of leaks through the frontal sinus were challenging and was associated with a high rate of complications.
PubMed: 37206806
DOI: 10.1007/s12070-022-03272-1 -
The Laryngoscope Feb 2022Dupilumab, a fully human monoclonal antibody that blocks the shared interleukin (IL)-4/IL-13 receptor component, significantly improved outcomes for patients with... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES/HYPOTHESIS
Dupilumab, a fully human monoclonal antibody that blocks the shared interleukin (IL)-4/IL-13 receptor component, significantly improved outcomes for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the SINUS-24 and SINUS-52 studies. This post hoc analysis evaluated dupilumab's effect on patient-reported symptoms and objective outcome measures using thresholds of clinically meaningful within-patient change from baseline.
METHODS
Patients with CRSwNP receiving subcutaneous dupilumab or placebo every 2 weeks in SINUS-24/SINUS-52 were analyzed. Patients recorded severity of nasal congestion (NC), loss of smell (LoS), and anterior/posterior rhinorrhea (each within range 0-3) daily. Total Symptom Score (TSS) was calculated as a composite severity score (0-9) for these symptoms. Objective measures included University of Pennsylvania Smell Identification Test (UPSIT; 0-40), nasal polyps score (NPS; 0-8), and Lund-Mackay computed tomography score (LMK-CT; 0-24). Thresholds of within-patient change in scores from baseline at weeks 24 and 52 considered clinically meaningful were ≥1.0 (NC, LoS), ≥3.0 (TSS), ≥8.0 (UPSIT), ≥1.0 (NPS), and ≥5.0 (LMK-CT).
RESULTS
A total of 724 and 303 patients were included in the week 24 and 52 analyses, respectively. Responder rates were significantly higher with dupilumab versus placebo at week 24 for NC (64% vs. 24%), LoS (63% vs. 14%), TSS (62% vs. 15%), UPSIT (54% vs. 6%), NPS (63% vs. 14%), and LMK-CT (59% vs. 3%); all P < .0001. Results were consistent at week 52.
CONCLUSION
Significantly greater proportions of dupilumab-treated patients with CRSwNP compared with placebo demonstrated clinically meaningful improvements in patient-reported sinonasal symptoms and objective outcomes.
LEVEL OF EVIDENCE
2 Laryngoscope, 132:259-264, 2022.
Topics: Adult; Aged; Antibodies, Monoclonal, Humanized; Chronic Disease; Double-Blind Method; Female; Humans; Male; Middle Aged; Nasal Polyps; Patient Reported Outcome Measures; Rhinitis; Sinusitis; Treatment Outcome
PubMed: 34817082
DOI: 10.1002/lary.29911 -
The Cochrane Database of Systematic... Apr 2015Basilar skull fractures predispose patients to meningitis because of the possible direct contact of bacteria in the paranasal sinuses, nasopharynx or middle ear with the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Basilar skull fractures predispose patients to meningitis because of the possible direct contact of bacteria in the paranasal sinuses, nasopharynx or middle ear with the central nervous system (CNS). Cerebrospinal fluid (CSF) leakage has been associated with a greater risk of contracting meningitis. Antibiotics are often given prophylactically, although their role in preventing bacterial meningitis has not been established.
OBJECTIVES
To evaluate the effectiveness of prophylactic antibiotics for preventing meningitis in patients with basilar skull fractures.
SEARCH METHODS
We searched CENTRAL (2014, Issue 5), MEDLINE (1966 to June week 1, 2014), EMBASE (1974 to June 2014) and LILACS (1982 to June 2014). We also performed an electronic search of meeting proceedings from the American Association of Neurological Surgeons (1997 to September 2005) and handsearched the abstracts of meeting proceedings of the European Association of Neurosurgical Societies (1995, 1999 and 2003).
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing any antibiotic versus placebo or no intervention. We also identified non-RCTs to perform a separate meta-analysis in order to compare results.
DATA COLLECTION AND ANALYSIS
Three review authors independently screened and selected trials, assessed risk of bias and extracted data. We sought clarification with trial authors when needed. We pooled risk ratios (RRs) for dichotomous data with their 95% confidence intervals (CIs) using a random-effects model. We assessed the overall quality of evidence using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach.
MAIN RESULTS
In this update we did not identify any new trials for inclusion. We included five RCTs with 208 participants in the review and meta-analysis. We also identified 17 non-RCTs comparing different types of antibiotic prophylaxis with placebo or no intervention in patients with basilar skull fractures. Most trials presented insufficient methodological detail. All studies included meningitis in their primary outcome. When we evaluated the five included RCTs, there were no significant differences between antibiotic prophylaxis groups and control groups in terms of reduction of the frequency of meningitis, all-cause mortality, meningitis-related mortality and need for surgical correction in patients with CSF leakage. There were no reported adverse effects of antibiotic administration, although one of the five RCTs reported an induced change in the posterior nasopharyngeal flora towards potentially more pathogenic organisms resistant to the antibiotic regimen used in prophylaxis. We performed a subgroup analysis to evaluate the primary outcome in patients with and without CSF leakage. We also completed a meta-analysis of all the identified controlled non-RCTs (enrolling a total of 2168 patients), which produced results consistent with the randomised data from the included studies.Using the GRADE approach, we assessed the quality of trials as moderate.
AUTHORS' CONCLUSIONS
Currently available evidence from RCTs does not support prophylactic antibiotic use in patients with basilar skull fractures, whether there is evidence of CSF leakage or not. Until more research is available, the effectiveness of antibiotics in patients with basilar skull fractures cannot be determined because studies published to date are flawed by biases. Large, appropriately designed RCTs are needed.
Topics: Antibiotic Prophylaxis; Cerebrospinal Fluid Leak; Cerebrospinal Fluid Rhinorrhea; Humans; Meningitis, Bacterial; Randomized Controlled Trials as Topic; Skull Fracture, Basilar
PubMed: 25918919
DOI: 10.1002/14651858.CD004884.pub4 -
Annals of Maxillofacial Surgery 2019Timely, expeditious and appropriate management of Frontal bone fractures and associated Frontal Sinus (FS) injuries are both crucial as well as challenging. Treatment...
BACKGROUND
Timely, expeditious and appropriate management of Frontal bone fractures and associated Frontal Sinus (FS) injuries are both crucial as well as challenging. Treatment options vary considerably, depending upon the nature, extent and severity of these injuries as well as operator skill, expertise and experience. In cases of posterior table fractures of the Frontal Sinus, literature reports have in general, propounded direct visualization and exploration of the sinus via a bifrontal craniotomy, followed by sinus cranialization.
AIMS AND OBJECTIVES
To review the standard protocols of management of Frontal bone fractures and Frontal Sinus injuries. To assess the efficacy of a more conservative approach in the management of outer and inner table fractures of the FS.
MATERIALS AND METHODS
Contemporary and evolving management protocols and changing treatment paradigms of different types and severities of frontal bone fractures and frontal sinus injuries, have been presented in this case series. A useful Treatment Algorithm has been proposed to efficiently and effectively manage these injuries.
RESULTS
In the present case series, effective and satisfactory results could be achieved in cases of significantly displaced inner and outer table fractures of the Frontal sinus by a more conservative protocol comprising of open reduction and internal fixation carried out via the existing scar of injury, without having to resort to the more radical intracranial approach and sinus cranialization. Nevertheless, presence of complicating factors such as cerebrospinal fluid rhinorrhea, evidence of meningitis or the development of encephalomeningocoeles necessitated the standard protocol of sinus exploration and its cranialization or obliteration.
CONCLUSION
Management protocols of Frontal Sinus injuries vary, based on aspects such as the timing of presentation and intervention, degree of injury sustained, concomitant associated Craniomaxillofacial injuries present, presence of complicating factors or Secondary/Residual deformities & Functional debility, and need to be decided upon on a case to case basis.
PubMed: 31909005
DOI: 10.4103/ams.ams_151_19 -
Journal of Neurosurgery. Case Lessons Mar 2023Spontaneous rhinorrhea may be the initial manifestation of ecchordosis physaliphora (EP). There are currently 47 published cases of symptomatic EP, with spontaneous...
BACKGROUND
Spontaneous rhinorrhea may be the initial manifestation of ecchordosis physaliphora (EP). There are currently 47 published cases of symptomatic EP, with spontaneous rhinorrhea being one of the most prevalent symptoms. The authors report 1 case as a cause of cerebrospinal fluid (CSF) fistula.
OBSERVATIONS
A 46-year-old woman presented to the authors' clinic with meningitis secondary to nasal CSF leakage. The computed tomography (CT) scan indicated an imperceptibly thin/dehiscent focus along the posterior wall of the sphenoid air cell's midline. A tumor was identified during endoscopic endonasal CSF repair surgery. EP was diagnosed in the frozen and final pathology.
LESSONS
EP should be considered as a potential cause of spontaneous rhinorrhea. This initial clinical manifestation accounts for 35% of symptomatic EP cases. The prepontine and posterior sphenoid sinus wall appear to be the locations with the highest susceptibility. Surgical therapy of the fistula without excision of the lesion may result in insufficient issue resolution and recurrence.
PubMed: 37014027
DOI: 10.3171/CASE236 -
Clivus pathologies from diagnosis to surgical multidisciplinary treatment. Review of the literature.Acta Otorhinolaryngologica Italica :... Apr 2021
Review
Topics: Cranial Fossa, Posterior; Humans; Skull Base Neoplasms
PubMed: 34060519
DOI: 10.14639/0392-100X-suppl.1-41-2021-04 -
Iranian Journal of Otorhinolaryngology Jan 2021There are many fibrin-derived sealants used as topical haemostatic agents in many surgical procedures. Fibrin sealants are usually non-autologous derivatives or animal...
INTRODUCTION
There are many fibrin-derived sealants used as topical haemostatic agents in many surgical procedures. Fibrin sealants are usually non-autologous derivatives or animal derivatives, with the exception of Vivostat®, an autologous fibrin sealant derived from patients own blood.
MATERIALS AND METHODS
We present our experience on the use of Vivostat® in skull base closures in 20 patients operated at the Otorhinolaryngology Unit of the Hospital Ospedali Riuniti Villa Sofia - Cervello of Palermo. All postoperative patients were placed in an anti-trendeleburg position for 48 hours. After removal of the nasal swabs we did not find any rhinorrhea and we checked the tightness of the skull base defect with computed tomography.
RESULTS
On a total of the 20 patients (10 post-traumatic and 10 with iatrogenic leaks), 9 out of 10 post-traumatic cases had a leak in the border area between the anterior and posterior portion of the ethmoid, while 1 patient out of 10 post-traumatic cases had a leak at the level of the sella. In all 20 patients, we repaired skull base defects by fixing grafting materials with Vivostat®. We have not had any complications. Vivostat® is a useful product in skull base repair and safe for the patients.
CONCLUSION
Vivostat® has been used as a sealant on body tissues with greater elasticity and more resistant allowing better and safer wound repair, especially in skull base surgery. In particular, its immediate polymerisation is very useful for an evaluation of the mechanical sealants in the closure of the skull base cerebrospinal fluid leak.
PubMed: 33654684
DOI: 10.22038/ijorl.2020.42520.2385 -
World Neurosurgery Jun 2015To analyze outcomes after the management of mild (<1 mm) and moderately severe (>1 mm and <5 mm) breaches of the posterior wall of the frontal sinus with a goal of...
OBJECTIVE
To analyze outcomes after the management of mild (<1 mm) and moderately severe (>1 mm and <5 mm) breaches of the posterior wall of the frontal sinus with a goal of maintaining or restoring the functional status of the sinus.
METHODS
A retrospective analysis of prospectively accrued data was performed on patients with mild and moderately severe breaches of the posterior wall of their frontal sinus who were managed with the intent to preserve the frontal sinus. Data on presenting features, pathology, details on breaches of the posterior wall, management, outcome, and complications were collected from medical records and neuroimages.
RESULTS
Forty-two cases met inclusion criteria. Diagnostic categories included trauma in 34 cases, infection in 3, and other categories in another 5 cases. Five presented with cerebrospinal fluid rhinorrhea, and 26 had radiographic evidence of obstruction of a nasofrontal duct at time of presentation. Fifteen patients were managed without surgical intervention, and 27 underwent surgery. No complications occurred in the patients managed without surgery and 4 postoperative cerebrospinal leaks that were managed successfully with a period of drainage occurred in the surgical group. No patient developed meningitis or mucocele.
CONCLUSIONS
Many patients with mild to moderately severe breaches of the posterior wall of the frontal sinus can be managed safely and effectively by techniques that preserve the anatomy and function of the frontal sinus.
Topics: Adolescent; Adult; Aged; Cerebrospinal Fluid Rhinorrhea; Child; Craniocerebral Trauma; Female; Frontal Sinus; Frontal Sinusitis; Humans; Male; Middle Aged; Neurosurgical Procedures; Organ Sparing Treatments; Paranasal Sinus Neoplasms; Retrospective Studies; Severity of Illness Index
PubMed: 25527881
DOI: 10.1016/j.wneu.2014.12.023 -
Indian Journal of Otolaryngology and... Oct 2019Acquired nasopharyngeal stenosis after radiotherapy for NPC is rare. We report a case of bilateral choanal stenosis and nasopharygeal stenosis in patient treated with...
INTRODUCTION
Acquired nasopharyngeal stenosis after radiotherapy for NPC is rare. We report a case of bilateral choanal stenosis and nasopharygeal stenosis in patient treated with chemo radiotherapy for undifferentieted nasopharnygeal carcinoma.
CASE REPORT
A 68 years old man treated for undifferentiated nasopharyngeal carcinoma with chemo-radiotherapy 10 years before. He complained of complete nasal obstruction, rhinorrhea, anosmia, snoring and hearing loss. Clinical examination and imaging revealed bilateral choanal stenosis and nasopharyngeal stenosis. Patient underwent a transnasal endoscopic resection for scar tissue with stenting of posterior choanae. Restenosis was noted just after stent removal. Second endoscopic resection of stenosis was done, followed by application of mitomycin-C without stenting. Several months later, the patient has good airflow, a patent nasopharynx without reccurence of stenosis.
DISCUSSION
The use of topical mitomycin-C may prove useful in the treatment and prevention of subsequent restenosis and scar formation in larynx and tracheal. Mitomycin-C application has being shown useful in treating nasopharyngeal stenosis. It is safely used topically in various surgical sites without major side effect.
CONCLUSION
Nasopharyngeal stenosis is an unusual complication of radiotherapy that can be successfully treated with combine two modalities: surgical and mitomycin-C as an adjunct.
PubMed: 31741924
DOI: 10.1007/s12070-015-0954-0