Balloon Sinuplasty Efficiency in Maxillary Rhinosinusitis.

Launched by TAMPERE UNIVERSITY HOSPITAL · Nov 19, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called balloon sinuplasty for people with chronic or recurring maxillary sinusitis, which is a type of sinus infection that affects the maxillary sinuses located near your cheeks. The goal of the study is to see how effective balloon sinuplasty is compared to a placebo (a treatment with no active ingredients) and to identify which patients benefit the most from this procedure. The trial is taking place at Tampere University Hospital and is looking to involve 120 patients aged 18 to 70 who have not had success with other treatments.

Participants in the trial will be randomly assigned to either receive the balloon sinuplasty treatment or a placebo, and their progress will be followed for one year after the procedure. They'll be asked questions and undergo tests to measure improvements in their sinus symptoms, including how often they experience infections and how they feel overall. It’s important to note that patients with specific conditions, such as nasal polyps or recent nasal surgery, are not eligible for participation. If you or someone you know struggles with sinus issues, this study may provide a new option for relief.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients at least 18 years old and younger than 70 years old
• • Patients willing to participate in the study
• • Patients whose diseases fill the definitions of chronic or acute recurrent maxillary rhinosinusitis
• • Patients with chronic maxillary rhinosinusitis has not responded to a 3-month trial of topical corticosteroid treatment
• • SNOT-22 points 8 or more in chronic maxillary rhinosinusitis
• • In recurrent acute maxillary rhinosinusitis, no SNOT-22 point limits are used
• * Modified Lund-Mackay inclusion criteria in chronic rhinosinusitis group:
• • 1. Maxillar 0-2
• • 2. Anterior Ethmoid 0-2
• • 3. Posterior Ethmoid 0-1
• • 4. Sphenoid 0-1
• • 5. Frontal 0-1
• • 6. Ostiomeatal complex 0 or 2
• Exclusion Criteria:
• • Chronic rhinosinusitis with nasal polyps
• • Notable inflammation in the ethmoidal, sphenoidal or frontal sinuses along with maxillary sinusitis
• • Previous nasal surgery
• • Sinonasal tumor
• • Maxillary rhinosinusitis caused by a dental problem
• • Facial pain caused by other etiologies
• • Cystic fibrosis
• • Gross immunodeficiency
• • Congenital mucociliary problems
• • Non-invasive fungal balls and invasive fungal disease
• • Systemic vasculitis and granulomatous disease
• • Severe systemic diseases
• • Malignancies
• • Pregnancy
• Definitions:
• Recurrent acute maxillary rhinosinusitis:
• • 4 or more episodes (\< 12 weeks) of acute rhinosinusitis with typical symptoms per year and no persistent symptoms between the rhinosinusitis episodes (Chan and Kuhn 2009)
• * The diagnosis of the recurrent episodes of acute rhinosinusitis have been made with the following criteria:
• • Increase of symptoms after 5 days or persistent symptoms after 10 days and
• • During the episode, 2 or more symptoms, one of which should be either nasal blockage/obstruction or nasal discharge (anterior/posterior nasal drip)
• • +/- facial pain/pressure
• • +/- reduction or loss of smell (Fokkens et al. 2012) and either
• • Signs of mucopurulent discharge primarily from the middle meatus seen in anterior rhinoscopy or nasoendoscopy and/or
• • Oedema/mucosal obstruction primarily seen in the middle meatus in anterior rhinoscopy or nasoendoscopy and/or
• • Signs of mucopurulent discharge seen in the nasopharynx or posterior oropharynx and/or
• • Signs of acute maxillary sinusitis is seen in sinus X-rays or CT/CBCT scans and/or
• • Signs of acute maxillary sinusitis seen in the sinus ultrasound
• • No signs of mucosal disease at nasoendoscopy during the asymptomatic period
• • At most, minor signs of inflammation in the maxillary sinuses and/or ostiomeatal complex in CT/CBCT scans during the asymptomatic period
• • Maximum 2-3 mm mucosal thickness in maxillary sinus medial and lateral wall
• Chronic maxillary rhinosinusitis:
• • Presence of typical symptoms of chronic rhinosinusitis for equal or longer than 12 weeks
• • 2 or more symptoms, one of which should be either nasal blockage/obstruction or nasal discharge (anterior/posterior nasal drip)
• • +/- facial pain/pressure
• • +/- reduction or loss of smell and either
• • Endoscopic signs of mucopurulent discharge primarily from middle meatus and/or
• • Endoscopic signs of oedema/mucosal obstruction primarily in middle meatus and/or
• • Inflammatory mucosal changes within the ostiomeatal complex and/or sinus in the CT/CBCT scans and the changes are limited mainly into maxillary sinuses (Fokkens et al. 2012)
• • The patients are not recruited in the study while they are having an exacerbation of chronic rhinosinusitis or an ongoing acute rhinosinusitis. Neither are the follow-up visits carried out during these episodes but postponed later. This way it can be ensured that the preoperative evaluation and the follow-up evaluation correspond with each other.