Randomized, controlled study of the effect of local and systemic factors on the postoperative course of patients with chronic rhinosinusitis (CRS) who underwent functional endoscopic sinus surgery (FESS).
- Conditions
- chronic rhinosinusitisRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12621000691842
- Lead Sponsor
- Aristotle Univeristy of Thessaloniki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 88
Patients were at least 18 years old, diagnosed with CRS with or without nasal polyposis (EPOS) and scheduled for bilateral functional endonasal endoscopic sinus surgery (FESS) or bilateral revision FESS. Patients with cystic fibrosis, immunodeficiencies, mucociliary dysfunction, fungal balls, systemic vasculitis, granulomatous diseases or cocaine abuse were excluded. The indication for surgery was made when medical treatment as recommended by the EPOS treatment algorithms failed, including saline irrigations, nasal corticosteroids, and one or more courses with oral treatment with oral corticosteroids and/or antibiotics. Nasal corticosteroids were stopped one week before surgery. Systemic corticosteroid drugs were stopped for at least one month before surgery.
The following are defined as exclusion criteria for patients:
Immunotherapy, decongestants (oral or nasal), cromolyns, ipatropium bromide, montelukast and monoclonal antibodies were prohibited before and during the study.
history of recent upper respiratory infection or exacerbation of chronic rhinosinusitis up to 3 weeks before surgery.
Chronic steroid intake for any reason other than chronic rhinosinusitis.
Medical history of head and neck cancer and radiotherapy in the head area.
Medical history of substance abuse or alcohol.
Hypersensitivity to doxycycline.
Taking other medications that could affect doxycycline intake.
Patients with known severe liver, kidney, skin or GI disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome was change in SNOT-22 score 2 months after surgery. Patients were categorized according to baseline SNOT-22 score, and the proportion of patients achieving a SNOT-22 minimal clinically important difference (MCID) of 8.9 was calculated, as well as the percentage change in SNOT-22 score.[ Baseline, 1st month, 2nd month (primary timepoint, 6th month.];Primary outcome 2 was change in Lund-Kennedy endoscopic score 2 months after surgery. Patients were categorized according to baseline Lund-Kennedy score and the percentage change on the first, second and sixth month.[ Baseline, 1st month, 2nd month (primary timepoint), 6th month.];Another primary outcome was change in Lund-Mackay radiological score in CT 6 months after surgery. Patients were categorized according to baseline Lund-Mackay score and the percentage change on the sixth month.[ Baseline, 6th month (primary timepoint)]
- Secondary Outcome Measures
Name Time Method A secondary outcome was change in Global Osteitis Scoring Scale in CT 6 moths after surgery. Patients were categorized according to baseline GOSS score and the percentage change on the sixth month.[ 0 and 6th month];Secondary outcome 2 was the absolute number of appointments needed, postoperatively, for debridement of the nasal cavity and VAS score for patient’s discomfort during debridement.[ 0, 1st, 2nd, 3rd, 4th, 8th week]