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| Name | Class |
|---|---|
| Tampere University Hospital | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Conservative treatment including nasal corticosteroids, nasal douching and other allergy medication as necessary. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic sinus surgery (ESS) | Procedure | Uncinectomy, middle meatal antrostomy by enlarging the natural maxillary ostium and partial ethmoidectomy or septoplasty according to clinical evaluation of the operator. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5-6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heidi M Kaski, MD | Contact | +385442730022 | heidi.kaski@student.oulu.fi |
| Name | Affiliation | Role |
|---|---|---|
| Olli-Pekka Alho, MD, PhD | Oulu University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Recruiting | Oulu | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42313411 | Derived | 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 Jun 18:e261537. doi: 10.1001/jamaoto.2026.1537. Online ahead of print. | |
| 34496924 | Derived | Kaski 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2020 | Sep 4, 2020 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D015523 | Maxillary Sinusitis |
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| 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) |
| 5-6 months |
| Difference in numbers of sinusitis episodes | Difference in the numbers of sinusitis episodes between the ESS and control groups. | 5-6 months |
| Difference in numbers of medical visits | Difference in the numbers of medical visits between the ESS and control groups. | 5-6 months |
| Difference in numbers of antimicrobial treatments | Difference in the numbers of antimicrobial treatments between the ESS and control groups. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 5-6 months |
| Adverse effects - postoperative synechia formation | Frequency of postoperative synechia formations in the ESS group | 5-6 months |
| Adverse effects - postoperative infection | Frequency of postoperative infections in the ESS group | 5-6 months |
| Adverse effects - postoperative orbital complication | Frequency of postoperative orbital complications in the ESS group | 5-6 months |
| Adverse effects - postoperative intracranial complication | Frequency of postoperative intracranial complications in the ESS group | 5-6 months |
| Tampere University Hospital | Recruiting | Tampere | Finland |
|
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |