Maxillary SinusitisNCT04241016
Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis
A study testing Endoscopic sinus surgery (ESS) in people with Maxillary Sinusitis and Sinusitis, Acute, run by Oulu University Hospital at 2 sites in Finland.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillary Sinusitis, Sinusitis, Acute, Sinusitis
- What is being tested?
- Endoscopic sinus surgery (ESS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFinland
- Study dates
- 1 May 2020to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 3 acute sinusitis episodes during previous 6 months or 4 acute sinusitis episodes during previous 12 months or at least 2 episodes per year for 3 consecutive years
- 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)
Who cannot join
- 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 8 in paranasal sinus CBCT scanning
Trial locations and contacts
2 sites in 1 country.
Finland2 sites, 2 recruiting
- Recruiting
Oulu University Hospital
Oulu
Heidi M Kaski, MD, +384442730022, heidi.kaski@student.oulu.fi
- Recruiting
Tampere University Hospital
Tampere
Saara Sillanpää, MD, +358 3 311 611, saara.sillanpaa@pirha.fi
Merja Rumpunen, Ms, +358 3 311 611, merja.rumpunen@pirha.fi
About this study
Official title: A Randomised Controlled Study of Endoscopic Sinus Surgery for Recurrent Acute Rhinosinusitis
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.
Read the 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.
- Conditions
- Maxillary Sinusitis, Sinusitis, Acute, Sinusitis
- Being tested
- Endoscopic sinus surgery (ESS)
- Keywords
- adult, endoscopic sinus surgery
- Medical subject headings
- Maxillary Sinusitis, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic sinus surgery (ESS)Procedure or surgery
Uncinectomy, middle meatal antrostomy by enlarging the natural maxillary ostium and partial ethmoidectomy or septoplasty according to clinical evaluation of the operator.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic sinus surgery (ESS) | Active comparator | 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. Receives: Procedure: Endoscopic sinus surgery (ESS) |
| Control | No intervention | Conservative treatment including nasal corticosteroids, nasal douching and other allergy medication as necessary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinonasal Outcome Test-22 score
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.
Measured: 5-6 months
Secondary outcomes (16)
36-Item Short Form Survey (SF-36, RAND) score
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.
Measured: 5-6 months
Difference in proportions of patients benefiting
Difference in proportions of patients benefiting clinically significantly from the treatment in ESS and control group (Minimum important change in SNOT-22 score)
Measured: 5-6 months
Difference in numbers of sinusitis episodes
Difference in the numbers of sinusitis episodes between the ESS and control groups.
Measured: 5-6 months
Difference in numbers of medical visits
Difference in the numbers of medical visits between the ESS and control groups.
Measured: 5-6 months
Difference in numbers of antimicrobial treatments
Difference in the numbers of antimicrobial treatments between the ESS and control groups.
Measured: 5-6 months
Difference in numbers of days lost from work or studies
Difference in the numbers of days lost from work or studies between the ESS and control groups.
Measured: 5-6 months
Difference in numbers of days with nasal obstruction
Difference in the numbers of days with nasal obstruction between the ESS and control groups.
Measured: 5-6 months
Difference in numbers of days with nasal discharge
Difference in the numbers of days with nasal discharge between the ESS and control groups.
Measured: 5-6 months
Difference in numbers of days with facial pain or pressure
Difference in the numbers of days with facial pain or pressure between the ESS and control groups.
Measured: 5-6 months
Difference in numbers of days with nasal pain
Difference in the numbers of days with nasal pain between the ESS and control groups.
Measured: 5-6 months
Difference in numbers of days with nasal hemorrhage
Difference in the numbers of days with nasal hemorrhage between the ESS and control groups.
Measured: 5-6 months
Difference of numbers of days with fever
Difference in the numbers of days with fever (>37.5 Celsius) between the ESS and control groups.
Measured: 5-6 months
Adverse effects - postoperative synechia formation
Frequency of postoperative synechia formations in the ESS group
Measured: 5-6 months
Adverse effects - postoperative infection
Frequency of postoperative infections in the ESS group
Measured: 5-6 months
Adverse effects - postoperative orbital complication
Frequency of postoperative orbital complications in the ESS group
Measured: 5-6 months
Adverse effects - postoperative intracranial complication
Frequency of postoperative intracranial complications in the ESS group
Measured: 5-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 May 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maxillary SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital
- Responsible party
- Principal investigator, Olli-Pekka Alho, MD, Oulu University Hospital
- Investigators
- Olli-Pekka Alho, MD, PhD, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241016
- Sponsor's protocol ID
- 01234
- Status last verified
- May 2023
- First submitted
- 17 Jan 2020
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kaski H, Alakarppa A, Laajala A, Tokola P, Penna T, Lantto U, Ohtonen P, Alho OP. Endoscopic Sinus Surgery for Recurrent Acute Rhinosinusitis: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 Aug 1;152(8):776-782. doi: 10.1001/jamaoto.2026.1537.
PubMed 42313411Kaski HM, Alakarppa A, Lantto U, Laajala A, Tokola P, Penna T, Ohtonen P, Alho OP. Endoscopic sinus surgery (ESS) to change quality of life for adults with recurrent rhinosinusitis: study protocol for a randomized controlled trial. Trials. 2021 Sep 8;22(1):606. doi: 10.1186/s13063-021-05576-z.
PubMed 34496924
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Study of Endoscopic Sinus Surgery for Recurrent Acute Rhinosinusitis
- ClinicalTrials.gov ID
- NCT04241016
- Acronym / sponsor ID
- 01234
- Conditions
- Maxillary Sinusitis, Sinusitis, Acute, Sinusitis
- Keywords
- adult, endoscopic sinus surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- Tampere University Hospital
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic sinus surgery (ESS) | Active comparator | Procedure: 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. |
| Control | No intervention | –Conservative treatment including nasal corticosteroids, nasal douching and other allergy medication as necessary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 3 acute sinusitis episodes during previous 6 months or 4 acute sinusitis episodes during previous 12 months or at least 2 episodes per year for 3 consecutive years
- 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)
Key exclusion criteria (8 listed)
- Age under 18 years,
- Immunodeficiency or immunosuppression
- Pregnancy,
- Previous illness making same-day surgery unfeasible
- Ongoing antibiotic treatment for other reasons,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Endoscopic sinus surgery (ESS) |
Primary outcome
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.
16 secondary outcomes
36-Item Short Form Survey (SF-36, RAND) score
Time frame: 5-6 months
Difference in proportions of patients benefiting
Time frame: 5-6 months
Difference in numbers of sinusitis episodes
Time frame: 5-6 months
Difference in numbers of medical visits
Time frame: 5-6 months
Difference in numbers of antimicrobial treatments
Time frame: 5-6 months
Difference in numbers of days lost from work or studies
Time frame: 5-6 months
Difference in numbers of days with nasal obstruction
Time frame: 5-6 months
Difference in numbers of days with nasal discharge
Time frame: 5-6 months
Difference in numbers of days with facial pain or pressure
Time frame: 5-6 months
Difference in numbers of days with nasal pain
Time frame: 5-6 months
Difference in numbers of days with nasal hemorrhage
Time frame: 5-6 months
Difference of numbers of days with fever
Time frame: 5-6 months
Adverse effects - postoperative synechia formation
Time frame: 5-6 months
Adverse effects - postoperative infection
Time frame: 5-6 months
Adverse effects - postoperative orbital complication
Time frame: 5-6 months
Adverse effects - postoperative intracranial complication
Time frame: 5-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Derived from this study: PubMed 42313411Kaski H, Alakarppa A, Laajala A, Tokola P, Penna T, Lantto U, Ohtonen P, Alho OP. Endoscopic Sinus Surgery for Recurrent Acute Rhinosinusitis: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 Aug 1;152(8):776-782. doi: 10.1001/jamaoto.2026.1537.
- Derived from this study: PubMed 34496924Kaski HM, Alakarppa A, Lantto U, Laajala A, Tokola P, Penna T, Ohtonen P, Alho OP. Endoscopic sinus surgery (ESS) to change quality of life for adults with recurrent rhinosinusitis: study protocol for a randomized controlled trial. Trials. 2021 Sep 8;22(1):606. doi: 10.1186/s13063-021-05576-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olli-Pekka Alho, MD, PhD principal investigator
Oulu University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic sinus surgery (ESS) in people with Maxillary Sinusitis and Sinusitis, Acute, run by Oulu University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi M Kaski, MD (+385442730022, heidi.kaski@student.oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinonasal Outcome Test-22 score (time frame: 5-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04241016, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.