A Placebo Controlled Randomised Study of the Balloon Sinuplasty Efficiency in Chronic or Recurrent Maxillary Rhinosinusitis.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 69
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Finland
Tampere University Hospital
RECRUITING
Tampere
Contact Information
Primary
Johanna Luukkanen
johanna.luukkanen@tuni.fi
+358407480866
Backup
Markus Rautiainen
markus.rautiainen@tuni.fi
+3583 31164181
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 120
Treatments
Experimental: Chronic sinusitis: Balloon sinuplasty
30 patients with chronic maxillary sinusitis that are randomized to be treated with the real Balloon sinuplasty procedure of maxillary sinuses.
Sham_comparator: Chronic sinusitis: Placebo
30 patients with chronic maxillary sinusitis that are randomized to be treated with sham surgery.
Experimental: Recurrent sinusitis: Balloon sinuplasty
30 patients with recurrent maxillary sinusitis that are randomized to be treated with the real Balloon sinuplasty procedure of maxillary sinuses.
Sham_comparator: Recurrent sinusitis: Placebo
30 patients with recurrent maxillary sinusitis that are randomized to be treated with sham surgery.
Sponsors
Leads: Tampere University Hospital

This content was sourced from clinicaltrials.gov