Comparing two surgical procedures for Sinusitis
Phase 2
- Conditions
- Chronic rhinosinusitis with or without polyposis.Chronic sinusitis
- Registration Number
- IRCT2017051128006N1
- Lead Sponsor
- Tehran University of Medical Sciences, Vice chancellor for research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
CRS with or without nasal polyps; no Response to medical treatment; age 15 - 60
Exclusion criteria: Acute infection; Failure to complete medical treatment; immune system disorders; systemic disorders like hypertension, diabetes mellitus, chronic kidney disease and malignancy; pregnancy
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Edema of the nasal mucosa. Timepoint: One day before surgery and 1, 3 and 6 months after that. Method of measurement: Nasal Endoscopy.;The width of the middle meatus. Timepoint: One day before surgery and 1, 3 and 6 months after that. Method of measurement: Clinical examination and Nasal Endoscopy.;Endoscopic assessment of the nose. Timepoint: One day before surgery and 1, 3 and 6 months after that. Method of measurement: Nasal endoscopy by the Lund Kennedy scoring system.;Patient satisfaction from the nose. Timepoint: One day before surgery and 1, 3 and 6 months after that. Method of measurement: Questionnaire.;Surgeon satisfaction of the nose. Timepoint: One day before surgery and 1, 3 and 6 months after that. Method of measurement: Questionnaire.;Difficulty breathing. Timepoint: One day before surgery and 1, 3 and 6 months after that. Method of measurement: Questionnaire.
- Secondary Outcome Measures
Name Time Method The duration of surgery. Timepoint: Intraoperative. Method of measurement: The report surgery.;Blood lost during surgery. Timepoint: Intraoperative. Method of measurement: Questionnaire.;Recurrent nasal polyps. Timepoint: 1,3 and 6 months after surgery. Method of measurement: Nasal endoscopy.;Nasal congestion. Timepoint: One day before surgery and after that. Method of measurement: Questionnaire.