2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-26

Study Completion Date

2021-12-31

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.

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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.

Conditions

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Thyroid Nodule

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

thyroid nodules, plan for transoral thyroidectomy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2-day prophylactic antibiotics

use prophylactic antibiotic for 2 days after transoral thyroidectomy

Group Type EXPERIMENTAL

Amoxicillin Clavulanate

Intervention Type DRUG

compare the duration of antbiotic use: 2 day versus 7 day

7-day prophylactic antibiotic

use prophylactic antibiotic for 7 days after transoral thyroidectomy

Group Type OTHER

Amoxicillin Clavulanate

Intervention Type DRUG

compare the duration of antbiotic use: 2 day versus 7 day

Interventions

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Amoxicillin Clavulanate

compare the duration of antbiotic use: 2 day versus 7 day

Intervention Type DRUG

Other Intervention Names

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Augmentin

Eligibility Criteria

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Inclusion Criteria

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