2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

Conditions
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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: 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 Exclusion Criteria: Previous thyroid or parathyroid surgery History of radiation at neck Could not tolerate the general anesthesia.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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
Interventional Model Description: thyroid nodules, plan for transoral thyroidectomy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2-day prophylactic antibiotics<br>use prophylactic antibiotic for 2 days after transoral thyroidectomy | Drug: Amoxicillin Clavulanate<br>* compare the duration of antbiotic use: 2 day versus 7 day<br>* Other names: Augmentin;|
| Other: 7-day prophylactic antibiotic<br>use prophylactic antibiotic for 7 days after transoral thyroidectomy | Drug: Amoxicillin Clavulanate<br>* compare the duration of antbiotic use: 2 day versus 7 day<br>* Other names: Augmentin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative infection | incidence of post-operative infection | within one month after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-op complication | intensity of pain, measured by VAS(visual analogue score) | within one month after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transoral surgery