Status:
UNKNOWN
The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp
Lead Sponsor:
CHU de Quebec-Universite Laval
Conditions:
Chronic Sinus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a randomized, double-blind clinical trial on the prophylactic use of antibiotics in postoperative endoscopic sinus vs placebo surgery. Patients with chronic rhinosinusitis with or without poly...
Detailed Description
The severity of the disease will be evaluated preoperatively according to the SNOT-22 score, the visual analogue scale of nasal symptoms, the Lund-Mackay score on the CT-scan and the Modified Lund-Ken...
Eligibility Criteria
Inclusion
- 18 years old and over able to consent
- Patients with chronic rhinosinusitis and failure to maximal medical treatment
- Endoscopic sinus surgery with at least one of the following: maxillary antrostomy, ethmoidectomy, sphenoidotomy and / or frontal sinusotomy
Exclusion
- Antibiotherapy less than 2 weeks before the intervention
- Penicillin allergy
- Inability to establish follow-up
- Open sinus surgery or associated septorhinoplasty (simple septoplasty is not considered an exclusion criterion)
- Immunodeficiency
- Cystic fibrosis of the pancreas
- Pregnancy
- odontogenic sinusitis
- Fungal sinusitis
- Diabetic
- Ciliary dyskinesia
- Sinus neoplasia
- Patient requiring antibiotic prophylaxis for endocarditis
Key Trial Info
Start Date :
August 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT03809312
Start Date
August 14 2019
End Date
February 1 2021
Last Update
July 14 2020
Active Locations (1)
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1
Simon-Pierre Harvey-Bolduc
Québec, Canada, G1H0C2