Use of Perioperative Antibiotics in Endoscopic Sinus Surgery

Study Overview
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Brief Summary
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The objective of this study is to determine whether the use of postoperative antibiotics following ESS decreases postoperative infection rates. This is a multi-institutional prospective study involving Albert Einstein College of Medicine/Montefiore Medical Center, Columbia University Medical Center, Weill Cornell Medical College, Mount Sinai Health System, and New York University Langone Medical Center. The study design will be a multi-institutional prospective randomized controlled trial with parallel random groups assigned to receive postoperative antibiotics or no postoperative antibiotics. The investigators hypothesize that patients who receive postoperative antibiotics will have lower postoperative infection rates and improved postoperative sinonasal symptoms and nasal endoscopy scores.

Official Title
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Use of Perioperative Antibiotics in Endoscopic Sinus Surgery

Conditions
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Chronic Sinus Infection

Intervention / Treatment
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* Drug: Amoxi Clavulanate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with CRS with or without nasal polyposis or allergic fungal rhinosinusitis who present to the otolaryngology clinic who have been deemed suitable for bilateral ESS, and are over the age of 18 will be included. Exclusion Criteria: Patients with sinonasal tumors, allergies or adverse reactions to all of the antibiotics that will be used in this study (amoxicillin-clavulanate, doxycycline, clarithromycin), immunodeficiency, cystic fibrosis, pregnancy, or diabetes with nasal polyposis (inability to receive systemic steroids) will be excluded, as will patients who lack capacity to provide informed consent. Patients undergoing active treatment for malignancy will be excluded. Patients undergoing unilateral ESS or with nonabsorbable packing placed at the time of surgery will be excluded. Patients who have been on antibiotics within 2 weeks of the surgery date will be excluded. Patients with acute on chronic sinusitis or the presence of purulence at time of surgery will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibiotics<br>To receive postoperative antibiotics | Drug: Amoxi Clavulanate<br>* Postoperative antibiotics<br>|
| No Intervention: No antibiotics<br>Will not receive any postoperative antibiotics | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in postoperative infection |  | 8 weeks | 
| Improvement in postoperative endoscopy scores |  | 8 weeks | 
| Improvement in postoperative SNOT-22 scores |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic sinus surgery, antibiotics