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临床试验/NCT04268407
NCT04268407已完成不适用

2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
post-operative infection

研究概览

简要总结

In transoral thyroidectomy via vestibular approach (TOETVA), prophylactic antibiotic for 5~7 days is recommended for the clean-contaminated wound. In this study, the investigators design a 2-day versus 7-day antibiotic prophylaxis to compare the surgical result and infection rate.

详细描述

Remote-access thyroid surgery has gained popularity and has advanced significantly over the past two decades, given the patient desire to avoid cosmetically displeasing scarring. The mostly recently introduced remote thyroid surgery is the transoral endoscopic thyroid surgery via vestibular approach (TOETVA). Because of the several advantages comparing with other removeaccess thyroid surgery, making it nowadays growing in popularity since 2016. However, TOETVA carry some inherent risks, including mental nerve injury, tumor seeding and local recurrence, fibrosis-induced long-lasting pulling sensation below the lower jaws, and surgical site infection coming from the clean-contaminated environment of oral incision.

Comparing with clean wound via the traditional open surgery, TOETVA carry the potential risk of infection. Based on the author's recommendation, prophylactic antibiotic (augmentin) will be administered 30 minutes before incision at operative room, followed by 2-day course of intravenous antibiotic, then shift to 5-day course of oral antibiotic finally. Up to date, only few case complicating postoperative infection were reported with extremely low infection rate (<1%). Therefore, the investigators want to study the short-course (2 days) of antibiotic coverage is also effective to prevent surgical site infection. It was proved in the preliminary study, comprising 5 patients in each group (2-day course in the study group and 7-day course in the control group). Later, the investigators will recruit more patients (n=100) to confirm this study.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Suspicious or proved thyroid cancer with size smaller than 4cm
  • Symptomatic benign thyroid nodules less than 6cm in size
  • Thyroid cyst
  • Follicular neoplasm
  • Graves' disease

排除标准

  • Previous thyroid or parathyroid surgery
  • History of radiation at neck
  • Could not tolerate the general anesthesia.

研究组 & 干预措施

2-day prophylactic antibiotics

Experimental

use prophylactic antibiotic for 2 days after transoral thyroidectomy

干预措施: Amoxicillin Clavulanate (Drug)

7-day prophylactic antibiotic

Other

use prophylactic antibiotic for 7 days after transoral thyroidectomy

干预措施: Amoxicillin Clavulanate (Drug)

结局指标

主要结局

post-operative infection

时间窗: within one month after operation

incidence of post-operative infection

次要结局

  • post-op complication(within one month after operation)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yichia Chan

principal investigator

Chang Gung Memorial Hospital

研究点 (1)

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