2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

Chang Gung Medical Foundation

Status: Completed

Conditions: Thyroid Nodule

Treatments: Drug: Amoxicillin Clavulanate

Study type: Interventional

Funder types: Other

Identifiers

NCT04268407

201902024A3

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

2-day prophylactic antibiotics

Experimental group

Description:

use prophylactic antibiotic for 2 days after transoral thyroidectomy

Treatment:

Drug: Amoxicillin Clavulanate

7-day prophylactic antibiotic

Other group

Description:

use prophylactic antibiotic for 7 days after transoral thyroidectomy

Treatment:

Drug: Amoxicillin Clavulanate