The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp
NCT ID: NCT03809312
Last Updated: 2020-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
134 participants
INTERVENTIONAL
2019-08-14
2021-02-28
Brief Summary
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Detailed Description
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The extension of the CES and intraoperative findings will be noted. Patients who have an infection during the procedure (pus with positive culture) will be excluded from the study. During the surgery, 4 groups will be formed as described in the figure below. Patients will be divided according to the presence or absence of polyps at the endoscopy and randomized in one of the 2 groups by the pharmacy of the CHU of Quebec. This will provide either a prescription of Clavulin 875 mg per os twice daily for 10 days, or a placebo of similar visual appearance in the same dosage. A bioabsorbable dressing (NasoPore, Stryker) will be positioned at the mid-meatus level at the end of the procedure. Nasal irrigations of saline solution will be prescribed post-operatively (qid for 1 month) as well as intra-nasal corticosteroids bid after 1 week (usual treatment). The addition of systemic corticosteroids will be left to the judgment of the surgeon, noted and analyzed as a confounding factor.
Follow-up will be done at 2 weeks, 1 month, 3 months and 6 months post-surgery. Patients will have to complete the SNOT-22 quality of life score and the visual similar scale of nasal symptoms at each visit. Sinusoscopy will be recorded at scheduled visits postoperatively. A single blind evaluator (to limit inter-rater differences) will analyze the video recordings to establish the modified Lund-Kennedy endoscopic score for each patient. Middle-meat secretion culture will be performed if pus is present during sinusoscopy and an antibiotic prescribed if needed. The patient will have to fill in a diary of other medications (analgesics, narcotics, anti-inflammatories) as well as a diary of side effects that will be collected at the visit of a post-operative month.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Clavulin group with polyps
Group who will receive clavulin after the endoscopic sinus surgery in prophylactic and who have polyps in the surgery
Amoxicillin / Clavulanic acid 875mg / 125mg
Amoxicillin / Clavulanic acid 875 mg / 125 mg BID x 10 days
Placebo group with polyps
Group who will receive placebo after the endoscopic sinus surgery in prophylactic and who have polyps in the surgery
Placebos
Placebos BID x 10 days
Clavulin group without polyps
Group who will receive clavulin after the endoscopic sinus surgery in prophylactic and who haven't polyps in the surgery
Amoxicillin / Clavulanic acid 875mg / 125mg
Amoxicillin / Clavulanic acid 875 mg / 125 mg BID x 10 days
Placebo group without polyps
Group who will receive clavulin after the endoscopic sinus surgery in prophylactic and who haven't polyps in the surgery
Placebos
Placebos BID x 10 days
Interventions
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Amoxicillin / Clavulanic acid 875mg / 125mg
Amoxicillin / Clavulanic acid 875 mg / 125 mg BID x 10 days
Placebos
Placebos BID x 10 days
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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CHU de Quebec-Universite Laval
OTHER
Responsible Party
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Simon-Pierre Harvey-Bolduc
ENT resident
Locations
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Simon-Pierre Harvey-Bolduc
Québec, , Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ATBprophylacticCES
Identifier Type: -
Identifier Source: org_study_id
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