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This randomized study compares operative techniques in chronic rhinosinusitis with polyposis (CRSwNP) surgery. It aims to evaluate outcomes in asthma and CRSwNP, safety and costs. The investigators want to see if patients with certain clinical and/or genetic predispositions will benefit from extended surgery. They also aim to find biomarkers for detection and management models for of severe airway inflammation and to further develop markers for progressive disease forms.
Please see study protocol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended | Active Comparator | Extended sinus surgery including all sinuses |
|
| Limited | Active Comparator | Limited sinus surgery with partial ethmoidectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended endoscopic sinus surgery | Procedure | ESS of all sinuses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sino-nasal outcome test (SNOT-22) | Change from baseline in patient symptoms as measured by the Sino-Nasal Outcomes Test (SNOT-22) survey. Scores are measured from 0-5 in a 22 item validated survey. Total scores range from 0-110 with higher scores indicating greater burden of sinonasal symptoms. | Baseline, Post-intervention every 3 months during 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula Virkkula, Docent | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otorhinolaryngology, Helsinki University Hospital | Helsinki | 00380 | Finland | |||
| Kuopio University Hospital |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) can be shared.
Beginning 3 months and ending 3 years after article publication.
Researchers who provide a methodologically sound proposal.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2018 |
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| Limited endoscopic sinus surgery |
| Procedure |
Partial ethmoidectomy |
|
| Kuopio |
| Finland |
| Academic Medical Center | Amsterdam | 1105 | Netherlands |
| Oct 10, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D001249 | Asthma |
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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