Balloon Sinuplasty Efficiency in Maxillary Rhinosinusitis.
A Placebo Controlled Randomised Study of the Balloon Sinuplasty Efficiency in Chronic or Recurrent Maxillary Rhinosinusitis.
Tampere University Hospital
120 participants
Jun 1, 2021
INTERVENTIONAL
Conditions
Summary
This study is a prospective, randomized, placebo-controlled, double-blinded clinical study. The balloon sinuplasty treatment is compared to placebo effect in chronic or recurrent maxillary sinusitis. The purpose is to find out the efficacy of balloon sinuplasty of maxillary sinuses and the patients who get the best benefit from balloon sinuplasty. The investigators also want to find out if balloon sinuplasty of maxillary sinuses improves Eustachian tube dysfunction. The study is executed in the Department of Ear and Oral Diseases, Tampere University Hospital. 120 patients who have either recurrent acute or chronic rhinosinusitis without nasal polyposis and whose sinusitis is limited mainly into maxillary sinuses, are recruited in the study. The patients are allocated either into the chronic maxillary sinusitis (60 patients) or the recurrent maxillary sinusitis (60 patients) branch of the study. Then, the patients are consecutively randomized into two treatment groups in the proportion of 1 to 1: A) Balloon sinuplasty group and B) Placebo group. The treatment is performed according to the patient's group status and all the patients are followed 12 months postoperatively. The effect of balloon sinuplasty treatment in chronic maxillary rhinosinusitis is going to be measured primarily with the Sino-Nasal Outcome Test (SNOT-22). In recurrent acute maxillary rhinosinusitis, the effect of balloon sinuplasty treatment will be measured primarily with the number of acute rhinosinusitis infections. Besides this, number of antibiotic treatments and sick leaves are inquired, Visual Analog Scale (VAS) and Eustachian Tube Dysfunction Questionnaire (ETDQ-7) are used, rhinomanometry, Cone Beam Computed Tomography (CBCT), tympanometry, tubomanometry, nasal endoscopy and general evaluation of the patients clinical ORL-status are performed. Also pre- and postoperative biopsies are taken from the middle turbinates.
Eligibility
Inclusion Criteria12
- 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
- Maxillar 0-2
- Anterior Ethmoid 0-2
- Posterior Ethmoid 0-1
- Sphenoid 0-1
- Frontal 0-1
- Ostiomeatal complex 0 or 2
Exclusion Criteria39
- 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:
- 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
- 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.
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Interventions
A shapeable tip of the balloon dilatation device (Entellus XprESS LoProfile; Stryker Corporation, Kalamazoo, Michigan, U.S.A.), with maxillary bending, is inserted into the maxillary sinus ostium. Then guided with the tip, a flexible balloon (6 mm x 20 mm) is gently inserted into the ostium and inflated up to 12 atm for 15 seconds. The dilatation is repeated one more time. The same procedure is performed for both maxillary sinuses.
The middle meatus is gently palpated with a curved suction tip (the tip is not connected to a suction unit). The curved suction tip is placed medial to the uncinate process. In order to create a better placebo effect, the operating doctor says: "Now inflate the balloon up to 12 atm for 15 seconds." After 15 seconds the doctor says: "Deflate the balloon." This is repeated one more time. Similar procedure is carried out on both sides.
Locations(1)
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NCT04645511