Comparing Efficacy of Postoperative Antibiotic Use in Transoral Thyroidectomy: a Prospective Randomized Controlled Trial Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- CBC, CRP
研究概览
简要总结
Transoral endoscopic thyroid surgery is a emerging surgical technique for thyroid surgery. This study to investigate the need for postoperative antibiotics in transoral endoscopic thyroid surgery.
详细描述
To prevent possible infection from the oral cavity flora, most surgeons prescribe postoperative oral antibiotics more than 3 to 7 days after surgery. Currently, there's no clinical evidence that postoperative oral antibiotics is necessary or not in transoral endoscopic thyroid surgery. The investigator will conduct randomization after transoral thyroid surgery with two groups : postoperative oral antibiotics group versus no oral antibiotics group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who planned to Transoral endoscopic thyroidectomy
- •Age between 20 to 70
- •Voluntarily consenting to the study and study agreement
- •No local invasion or distant metastasis
- •Normal vocal cord function in laryngoscopic exam
- •No significant abnormalities in preoperative laboratory tests
排除标准
- •Take aspirin or antiplatelet drugs within 7 days before admission
- •Uncontrolled hypertension, diabetes, chronic renal failure, or coagulation disease
- •History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack)
- •Substance abuse and alcohol abuse
- •History of esophageal and airway diseases
- •Patient was participated in other clinical trials within 30 days
- •History of neck irradiation or surgery
- •History of drug allergies
- •Pregnant or lactating women
研究组 & 干预措施
Postop antibiotics group
Prescribe Amoxicillin Clavulanate
干预措施: Amoxicillin Clavulanate (Drug)
结局指标
主要结局
CBC, CRP
时间窗: Postoperative 1 day
Laboratory test
"CDC 1992 SSI table" score
时间窗: Postoperative 1 day
Clinical evidence of Surgical Site Infection
次要结局
- Change of "CDC 1992 SSI table" score(Compare the CDC 1992 SSI table score between postoperative 1 day and 2 day/2 weeks.)
- Change of CBC, CRP(Compare the CBC, CRP between postoperative 1 day and 2 day)
研究者
Jin Wook Yi
Clinical Assistant Professor
Seoul National University Hospital