Chronic Sinus Infection Clinical Trial
Official title:
The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp: A Randomized, Double-blind Clinical Trial
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 polyps who have consented to endoscopic sinus surgery according to Canadian practice guidelines may be included in the study after approval by the Research Ethics Board of the University Hospital Center. Quebec and signature of consent.
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-Kennedy endoscopic score (sinusoscopy will be recorded). Relevant demographics
and medical history of participants will also be collected preoperatively.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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N/A | |
| Withdrawn |
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|
Phase 2/Phase 3 | |
| Suspended |
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Use of Perioperative Antibiotics in Endoscopic Sinus Surgery
|
Phase 4 | |
| Suspended |
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|
N/A |