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Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241016
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Olli-Pekka Alho, MD, Oulu University Hospital

Brief Summary:
The aim of this study is to find out if endoscopic sinus surgery improves the quality of life in patients suffering from recurrent acute rhinosinusitis. Our main outcome is the difference between the average change in disease-specific SNOT-22 quality of life questionnaire scores (from baseline to 5-6 months follow-up) between the intervention and the control groups.

Condition or disease Intervention/treatment Phase
Maxillary Sinusitis Sinusitis, Acute Sinusitis Procedure: Endoscopic sinus surgery (ESS) Not Applicable

Detailed Description:
This is a randomized controlled trial. Patients suffering from recurrent acute sinusitis episodes will be randomly allocated to two groups: intervention group, where they will receive endoscopic sinus surgery in addition to medical treatment and control group, where they will receive mere medical treatment. Both groups will be followed-up for 5 to 6 months. At baseline and after 5 to 6 months, patients will answer the life quality questionnaires SNOT-22 and RAND 36-item Health Survey. The numbers of sinusitis episodes, medical appointments for respiratory symptoms, use of medications, numbers of days lost from work or studies and numbers of days with various respiratory and adverse symptoms will be recorded with patient diaries. The potential serious adverse events (e.g. cerebrospinal fluid leak, orbital complications) related to surgery will be collected from the medical records.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Study of Endoscopic Sinus Surgery for Recurrent Acute Rhinosinusitis
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : May 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: Endoscopic sinus surgery (ESS)
Endoscopic sinus surgery. Postoperative treatment consists of daily nasal douching, daily nasal steroid sprays, pain medication when necessary and at least one postoperative control visit including endoscopy two weeks after the operation. Additionally medical treatment including nasal corticosteroids, nasal douching and other allergy medication as necessary.
Procedure: Endoscopic sinus surgery (ESS)
Uncinectomy, middle meatal antrostomy by enlarging the natural maxillary ostium and partial ethmoidectomy or septoplasty according to clinical evaluation of the operator.

No Intervention: Control
Conservative treatment including nasal corticosteroids, nasal douching and other allergy medication as necessary.



Primary Outcome Measures :
  1. Sinonasal Outcome Test-22 score [ Time Frame: 5-6 months ]
    Difference between the mean disease-specific Sinonasal Outcome Test 22 (SNOT-22) change scores (from baseline to 5-6 months) of ESS and control group. SNOT-22 summary scores vary between 0 and 110 with higher values indicating poorer quality of life.


Secondary Outcome Measures :
  1. 36-Item Short Form Survey (SF-36, RAND) score [ Time Frame: 5-6 months ]
    Difference between the mean generic RAND-36 domains change scores (from baseline to 5-6 months) of ESS and control group. RAND-36 instrument produces eight individual values between 0 and 100 (one for each domain), with higher scores indicating better quality of life.

  2. Difference in proportions of patients benefiting [ Time Frame: 5-6 months ]
    Difference in proportions of patients benefiting clinically significantly from the treatment in ESS and control group (Minimum important change in SNOT-22 score)

  3. Difference in numbers of sinusitis episodes [ Time Frame: 5-6 months ]
    Difference in the numbers of sinusitis episodes between the ESS and control groups.

  4. Difference in numbers of medical visits [ Time Frame: 5-6 months ]
    Difference in the numbers of medical visits between the ESS and control groups.

  5. Difference in numbers of antimicrobial treatments [ Time Frame: 5-6 months ]
    Difference in the numbers of antimicrobial treatments between the ESS and control groups.

  6. Difference in numbers of days lost from work or studies [ Time Frame: 5-6 months ]
    Difference in the numbers of days lost from work or studies between the ESS and control groups.

  7. Difference in numbers of days with nasal obstruction [ Time Frame: 5-6 months ]
    Difference in the numbers of days with nasal obstruction between the ESS and control groups.

  8. Difference in numbers of days with nasal discharge [ Time Frame: 5-6 months ]
    Difference in the numbers of days with nasal discharge between the ESS and control groups.

  9. Difference in numbers of days with facial pain or pressure [ Time Frame: 5-6 months ]
    Difference in the numbers of days with facial pain or pressure between the ESS and control groups.

  10. Difference in numbers of days with nasal pain [ Time Frame: 5-6 months ]
    Difference in the numbers of days with nasal pain between the ESS and control groups.

  11. Difference in numbers of days with nasal hemorrhage [ Time Frame: 5-6 months ]
    Difference in the numbers of days with nasal hemorrhage between the ESS and control groups.

  12. Difference of numbers of days with fever [ Time Frame: 5-6 months ]
    Difference in the numbers of days with fever (>37.5 Celsius) between the ESS and control groups.

  13. Adverse effects - postoperative synechia formation [ Time Frame: 5-6 months ]
    Frequency of postoperative synechia formations in the ESS group

  14. Adverse effects - postoperative infection [ Time Frame: 5-6 months ]
    Frequency of postoperative infections in the ESS group

  15. Adverse effects - postoperative orbital complication [ Time Frame: 5-6 months ]
    Frequency of postoperative orbital complications in the ESS group

  16. Adverse effects - postoperative intracranial complication [ Time Frame: 5-6 months ]
    Frequency of postoperative intracranial complications in the ESS group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 3 acute sinusitis episodes during previous 6 months or 4 acute sinusitis episodes during previous 12 months
  • Episodes must last less than 4 weeks and be diagnosed and treated as acute rhinosinusitis by a physician
  • Episode symptoms include nasal discharge, nasal congestion, hyposmia and facial pressure or pain and the episodes have to be severe enough for the patient to seek medical help and for daily life to be significantly disturbed
  • Patients must have failed a three-month conservative therapy (medication for possible allergies, nasal corticosteroids and douching and courses of antibiotics as necessary)

Exclusion Criteria:

  • Age under 18 years,
  • Immunodeficiency or immunosuppression
  • Pregnancy,
  • Previous illness making same-day surgery unfeasible
  • Ongoing antibiotic treatment for other reasons,
  • Primary complaint of nasal septal deviation and
  • Chronic rhinosinusitis with or without nasal polyposis
  • Symptoms for over 12 weeks and/or Lund-Mackay score over 4 in paranasal sinus CBCT scanning

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241016


Contacts
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Contact: Heidi M Kaski, MD +385442730022 heidi.kaski@student.oulu.fi

Locations
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Finland
Oulu University Hospital Recruiting
Oulu, Finland
Contact: Heidi M Kaski, MD    +384442730022    heidi.kaski@student.oulu.fi   
Sponsors and Collaborators
Oulu University Hospital
Investigators
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Principal Investigator: Olli-Pekka Alho, MD, PhD Oulu University Hospital
  Study Documents (Full-Text)

Documents provided by Olli-Pekka Alho, MD, Oulu University Hospital:
Statistical Analysis Plan  [PDF] September 4, 2020

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Responsible Party: Olli-Pekka Alho, MD, Professor of Otorhinolaryngology, Oulu University Hospital
ClinicalTrials.gov Identifier: NCT04241016    
Other Study ID Numbers: 01234
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Olli-Pekka Alho, MD, Oulu University Hospital:
adult
endoscopic sinus surgery
Additional relevant MeSH terms:
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Sinusitis
Maxillary Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases