Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparing Efficacy of Postoperative Antibiotic Use in Transoral Thyroidectomy: a Prospective Randomized Controlled Trial Study

Conditions
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Surgical Wound Infection, Thyroid Nodule

Intervention / Treatment
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* Drug: Amoxicillin Clavulanate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Postop antibiotics group<br>Prescribe Amoxicillin Clavulanate | Drug: Amoxicillin Clavulanate<br>* Per-oral Amoxicillin Clavulanate Given or Non-given, after surgery<br>|
| No Intervention: No postop antibiotics<br>Do not prescribe Amoxicillin Clavulanate | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CDC 1992 SSI table score | Clinical evidence of Surgical Site Infection | Postoperative 1 day | 
| CBC, CRP | Laboratory test | Postoperative 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of CDC 1992 SSI table score | Clinical evidence of Surgical Site Infection | Compare the CDC 1992 SSI table score between postoperative 1 day and 2 day/2 weeks. | 
| Change of CBC, CRP | Laboratory test | Compare the CBC, CRP between postoperative 1 day and 2 day |