Balloon Sinuplasty Efficiency in Maxillary Rhinosinusitis.
Maxillary Sinusitis, Sinusitis, Chronic, Sinusitis Recurrent
About this trial
This is an interventional treatment trial for Maxillary Sinusitis focused on measuring Balloon sinuplasty
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:
- Maxillar 0-2
- Anterior Ethmoid 0-2
- Posterior Ethmoid 0-1
- Sphenoid 0-1
- Frontal 0-1
- 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.
Sites / Locations
- Tampere University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Sham Comparator
Experimental
Sham Comparator
Chronic sinusitis: Balloon sinuplasty
Chronic sinusitis: Placebo
Recurrent sinusitis: Balloon sinuplasty
Recurrent sinusitis: Placebo
30 patients with chronic maxillary sinusitis that are randomized to be treated with the real Balloon sinuplasty procedure of maxillary sinuses.
30 patients with chronic maxillary sinusitis that are randomized to be treated with sham surgery.
30 patients with recurrent maxillary sinusitis that are randomized to be treated with the real Balloon sinuplasty procedure of maxillary sinuses.
30 patients with recurrent maxillary sinusitis that are randomized to be treated with sham surgery.