Use of Perioperative Antibiotics in Endoscopic Sinus Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Postoperative Infection
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Antibiotics
To receive postoperative antibiotics
干预措施: Amoxi Clavulanate (Drug)
结局指标
主要结局
Postoperative Infection
时间窗: During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively
The number/percentage of participants with postoperative infection rate, as assessed by rigid nasal endoscopy in the office and culture of suspected infectious material noted within the paranasal sinuses will be reported. A postoperative infection as defined by having an infection at ANY of the postoperative visits AND detected initially by evidence of purulence on nasal endoscopy will be considered an infection if the culture swab from the site of purulence during that office visit confirms that there is an actual bacterial source of the infection.
次要结局
- Postoperative Sino-nasal Outcome Test (SNOT-22) Scores(During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively)
- Perioperative Sinus Endoscopy (POSE) Scores(During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively)