NCT04241016

Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis

A Randomised Controlled Study of Endoscopic Sinus Surgery for Recurrent Acute Rhinosinusitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Oulu University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-05-01
• Primary completion: 2024-12-31
• Completion: 2025-05-30
• First posted: 2020-01-27
• Last updated: 2023-05-31

Locations

2 sites across 1 country: Finland