Balloon Sinuplasty Efficiency in Maxillary Rhinosinusitis.

NCT04645511 | Recruiting DMC

• 1 other identifier: R20026
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Maxillary Sinusitis; Sinusitis, Chronic; Sinusitis Recurrent; Eustachian Tube Dysfunction

Keywords

Balloon sinuplasty

Outcome Measures

Primary Outcomes (7)

• Change from baseline Sino-Nasal Outcome Test (SNOT-22) score at 3 months

  The effect of balloon sinuplasty treatment in chronic maxillary rhinosinusitis is measured primarily with the Sino-Nasal Outcome Test (SNOT-22). The Sino-Nasal Outcome Test (SNOT-22) is a patient-reported measure of outcome developed for use in chronic rhinosinusitis with or without nasal polyposis. It can be used to assess the impact of chronic rhinosinusitis on the patient's quality of life. It may also be used to measure the outcome of a surgical intervention (Hopkins et al. 2009). In this study, SNOT-22 translated in Finnish is used. The validation of the Finnish version has been made by the Finnish Medical Society Duodecim.

  Patients fill the SNOT-22-questionnaire preoperatively and 3 months post-operative

• Change from baseline Sino-Nasal Outcome Test (SNOT-22) score at 6 months

  The effect of balloon sinuplasty treatment in chronic maxillary rhinosinusitis is measured primarily with the Sino-Nasal Outcome Test (SNOT-22). The Sino-Nasal Outcome Test (SNOT-22) is a patient-reported measure of outcome developed for use in chronic rhinosinusitis with or without nasal polyposis. It can be used to assess the impact of chronic rhinosinusitis on the patient's quality of life. It may also be used to measure the outcome of a surgical intervention (Hopkins et al. 2009). In this study, SNOT-22 translated in Finnish is used. The validation of the Finnish version has been made by the Finnish Medical Society Duodecim.

  Patients fill the SNOT-22-questionnaire preoperatively and 6 months post-operative

• Change from baseline Sino-Nasal Outcome Test (SNOT-22) score at 9 months

  The effect of balloon sinuplasty treatment in chronic maxillary rhinosinusitis is measured primarily with the Sino-Nasal Outcome Test (SNOT-22). The Sino-Nasal Outcome Test (SNOT-22) is a patient-reported measure of outcome developed for use in chronic rhinosinusitis with or without nasal polyposis. It can be used to assess the impact of chronic rhinosinusitis on the patient's quality of life. It may also be used to measure the outcome of a surgical intervention (Hopkins et al. 2009). In this study, SNOT-22 translated in Finnish is used. The validation of the Finnish version has been made by the Finnish Medical Society Duodecim.

  Patients fill the SNOT-22-questionnaire preoperatively and 9 months post-operative

• Change from baseline Sino-Nasal Outcome Test (SNOT-22) score at 12 months

  The effect of balloon sinuplasty treatment in chronic maxillary rhinosinusitis is measured primarily with the Sino-Nasal Outcome Test (SNOT-22). The Sino-Nasal Outcome Test (SNOT-22) is a patient-reported measure of outcome developed for use in chronic rhinosinusitis with or without nasal polyposis. It can be used to assess the impact of chronic rhinosinusitis on the patient's quality of life. It may also be used to measure the outcome of a surgical intervention (Hopkins et al. 2009). In this study, SNOT-22 translated in Finnish is used. The validation of the Finnish version has been made by the Finnish Medical Society Duodecim.

  Patients fill the SNOT-22-questionnaire preoperatively and 12 months post-operative

• Change from baseline in the number of acute rhinosinusitis infections at 3 months

  In recurrent acute maxillary rhinosinusitis, the effect of balloon sinuplasty treatment is measured primarily with the change in number of acute rhinosinusitis infections. It is hard to measure the effect of the balloon sinuplasty in recurrent acute rhinosinusitis with methods questioning the current state of disease, because patients are asymptomatic between episodes of sinusitis. That is why the patients are asked the number of maxillary rhinosinusitis during the last 3 months preoperatively and that number is compared to the number of postoperative maxillary rhinosinusitis asked at 3 months after the operation.

  Preoperative and 3 months post-operative

• Change from baseline in the number of acute rhinosinusitis infections at 6 months

  In recurrent acute maxillary rhinosinusitis, the effect of balloon sinuplasty treatment is measured primarily with the change in number of acute rhinosinusitis infections. It is hard to measure the effect of the balloon sinuplasty in recurrent acute rhinosinusitis with methods questioning the current state of disease, because patients are asymptomatic between episodes of sinusitis. The patients are asked the number of maxillary rhinosinusitis during the last 6 months preoperatively and that number is compared to the number of postoperative maxillary rhinosinusitis that the patients have had during the post-operative 6 months.

  Preoperative and 6 months post-operative

• Change from baseline in the number of acute rhinosinusitis infections at 12 months

  In recurrent acute maxillary rhinosinusitis, the effect of balloon sinuplasty treatment is measured primarily with the change in number of acute rhinosinusitis infections. It is hard to measure the effect of the balloon sinuplasty in recurrent acute rhinosinusitis with methods questioning the current state of disease, because patients are asymptomatic between episodes of sinusitis. The patients are asked the number of maxillary rhinosinusitis during the last 12 months preoperatively and that number is compared to the number of postoperative maxillary rhinosinusitis infections that the patients have had during the post-operative 12 months.

  Preoperative and 12 months post-operative

Secondary Outcomes (12)

• Amount of sick leaves

  Preoperative and 3, 6, 9 and 12 months post-operative

• Number of antibiotic treatments needed

  Preoperative and 3, 6, 9 and 12 months post-operative

• Eustachian Tube Dysfunction Questionnaire (ETDQ-7)

  Preoperative and 3, 6, 9 and 12 months post-operative

• Visual Analog Scale (VAS)

  Preoperative and 3, 6, 9 and 12 months post-operative

• The clinical status of nasal mucosa in nasal endoscopy assessed in terms of mucosal oedema, nasal discharge and synechiae

  Preoperative and during post-operative visits at 3 and 12 months

Other Outcomes (2)

• Adverse events

  3, 6, 9 and 12 months post-operative

• General evaluation of the patient and clinical ORL-status

  Preoperative and during post-operative visits at 3 and 12 months

Study Arms (4)

Chronic sinusitis: Balloon sinuplasty

EXPERIMENTAL

30 patients with chronic maxillary sinusitis that are randomized to be treated with the real Balloon sinuplasty procedure of maxillary sinuses.

Procedure: Balloon sinuplasty of maxillary sinuses

Chronic sinusitis: Placebo

SHAM COMPARATOR

30 patients with chronic maxillary sinusitis that are randomized to be treated with sham surgery.

Procedure: Sham surgery

Recurrent sinusitis: Balloon sinuplasty

EXPERIMENTAL

30 patients with recurrent maxillary sinusitis that are randomized to be treated with the real Balloon sinuplasty procedure of maxillary sinuses.

Procedure: Balloon sinuplasty of maxillary sinuses

Recurrent sinusitis: Placebo

SHAM COMPARATOR

30 patients with recurrent maxillary sinusitis that are randomized to be treated with sham surgery.

Procedure: Sham surgery

Interventions

Balloon sinuplasty of maxillary sinuses PROCEDURE

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.

Chronic sinusitis: Balloon sinuplasty; Recurrent sinusitis: Balloon sinuplasty

Sham surgery PROCEDURE

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.

Chronic sinusitis: Placebo; Recurrent sinusitis: Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

RECRUITING

Related Publications (10)

• Chan Y, Kuhn FA. An update on the classifications, diagnosis, and treatment of rhinosinusitis. Curr Opin Otolaryngol Head Neck Surg. 2009 Jun;17(3):204-8. doi: 10.1097/MOO.0b013e32832ac393.

  PMID: 19346944 BACKGROUND

• Clement PA, Halewyck S, Gordts F, Michel O. Critical evaluation of different objective techniques of nasal airway assessment: a clinical review. Eur Arch Otorhinolaryngol. 2014 Oct;271(10):2617-25. doi: 10.1007/s00405-013-2870-9. Epub 2014 Jan 20.

  PMID: 24442716 BACKGROUND

• Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Rhinol Suppl. 2012 Mar;23:3 p preceding table of contents, 1-298.

  PMID: 22764607 BACKGROUND

• Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.

  PMID: 19793277 BACKGROUND

• Jerger J. Clinical experience with impedance audiometry. Arch Otolaryngol. 1970 Oct;92(4):311-24. doi: 10.1001/archotol.1970.04310040005002. No abstract available.

  PMID: 5455571 BACKGROUND

• Liden G. The scope and application of current audiometric tests. J Laryngol Otol. 1969 Jun;83(6):507-20. doi: 10.1017/s0022215100070651. No abstract available.

  PMID: 5785649 BACKGROUND

• McCoul ED, Anand VK, Christos PJ. Validating the clinical assessment of eustachian tube dysfunction: The Eustachian Tube Dysfunction Questionnaire (ETDQ-7). Laryngoscope. 2012 May;122(5):1137-41. doi: 10.1002/lary.23223. Epub 2012 Feb 28.

  PMID: 22374681 BACKGROUND

• Schroder S, Lehmann M, Korbmacher D, Sauzet O, Sudhoff H, Ebmeyer J. Evaluation of tubomanometry as a routine diagnostic tool for chronic obstructive Eustachian tube dysfunction. Clin Otolaryngol. 2015 Dec;40(6):691-7. doi: 10.1111/coa.12451.

  PMID: 25925071 BACKGROUND

• Valtonen O, Bizaki A, Kivekas I, Rautiainen M. Three-Dimensional Volumetric Evaluation of the Maxillary Sinuses in Chronic Rhinosinusitis Surgery. Ann Otol Rhinol Laryngol. 2018 Dec;127(12):931-936. doi: 10.1177/0003489418801386. Epub 2018 Sep 22.

  PMID: 30244583 BACKGROUND

• Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.

  PMID: 2197679 BACKGROUND

MeSH Terms

Conditions

Maxillary Sinusitis; Sinusitis; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Markus Rautiainen, Professor

  Professor

  STUDY CHAIR

• Johanna Luukkanen, MD

  Doctoral thesis researcher

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Luukkanen

CONTACT

+358407480866; johanna.luukkanen@tuni.fi

Markus Rautiainen

CONTACT

+3583 31164181; markus.rautiainen@tuni.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Throughout the study, both the patients and the examining doctors are blinded regarding the patients' group status. The patients are randomized using a MINIM-program by a person, who doesn't participate in treating or following up the patients. The operating doctor only operates the patients but doesn't participate in the pre- or postoperative evaluation. The information, whether the patient had a placebo procedure or the balloon sinuplasty procedure, is not written in the patient's medical record but only on the Surgery form and the form is sealed in an envelope. The envelope is only opened in the end of the 12-month follow-up period. The patient's eyes are covered with moist gauze dressing pads during the operation and the staff pays extreme attention not to let the patient know his/her group status. Neither do the examining doctors know the patient's group status during the 12 month follow-up period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, randomized, placebo-controlled, double-blinded clinical study

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: November 27, 2020
• Study Start: June 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)