An interventional study of Endoscopic sinus surgery (ESS) in Maxillary Sinusitis, Sinusitis, Acute and Sinusitis, sponsored by Oulu University Hospital. Recruiting at 2 sites in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-31.
Sponsored by Oulu University Hospital · Not applicable, Interventional, and Treatment
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.
256 studies on the registry are indexed under Sinusitis; 23 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 196 interventional studies indexed under Sinusitis.
Browse Sinusitis studies →Oulu University Hospital is the lead sponsor of 40 studies on the registry; 17 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Conservative treatment including nasal corticosteroids, nasal douching and other allergy medication as necessary.
Uncinectomy, middle meatal antrostomy by enlarging the natural maxillary ostium and partial ethmoidectomy or septoplasty according to clinical evaluation of the operator.
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.
Time frame: 5-6 months
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.
Time frame: 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)
Time frame: 5-6 months
Difference in numbers of sinusitis episodes
Difference in the numbers of sinusitis episodes between the ESS and control groups.
Time frame: 5-6 months
Difference in numbers of medical visits
Difference in the numbers of medical visits between the ESS and control groups.
Time frame: 5-6 months
Difference in numbers of antimicrobial treatments
Difference in the numbers of antimicrobial treatments between the ESS and control groups.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5-6 months
Adverse effects - postoperative synechia formation
Frequency of postoperative synechia formations in the ESS group
Time frame: 5-6 months
Adverse effects - postoperative infection
Frequency of postoperative infections in the ESS group
Time frame: 5-6 months
Adverse effects - postoperative orbital complication
Frequency of postoperative orbital complications in the ESS group
Time frame: 5-6 months
Adverse effects - postoperative intracranial complication
Frequency of postoperative intracranial complications in the ESS group
Time frame: 5-6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Started May 2020 (actual). Primary completion is estimated for Dec 2024, 55 months after the start.
Of 29 interventional studies with no phase under Sinusitis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 63. This study's planned 55 months is above that.
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Oulu University Hospital