Clinical trial NCT03369717: Use of Perioperative Antibiotics in Endoscopic Sinus Surgery
Official title: Use of Perioperative Antibiotics in Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Sinus Infection
Keywords: endoscopic sinus surgery
antibiotics
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, New York
name: NYU Langone Health
name: Weill Medical College of Cornell University
name: Columbia University
First posted: 2017-12-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to determine whether the use of postoperative antibiotics following endoscopic sinus surgery (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.


Eligibility criteria: Inclusion Criteria:

* Patients with Chronic Rhinosinusitis (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.

Primary outcomes:
measure: Postoperative Infection
timeFrame: During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively
Secondary outcomes:
measure: Postoperative Sino-nasal Outcome Test (SNOT-22) Scores
timeFrame: During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively
measure: Perioperative Sinus Endoscopy (POSE) Scores
timeFrame: During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Assistant Professor
name: Nadeem Akbar, MD
role: PRINCIPAL_INVESTIGATOR
References: