2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

Not Applicable

Completed

• Conditions: Thyroid Nodule
• Interventions: Drug: Amoxicillin Clavulanate

• Registration Number: NCT04268407
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-13
• Study Start: 2020-02-26
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7-day prophylactic antibiotic	Amoxicillin Clavulanate	use prophylactic antibiotic for 7 days after transoral thyroidectomy
2-day prophylactic antibiotics	Amoxicillin Clavulanate	use prophylactic antibiotic for 2 days after transoral thyroidectomy

Primary Outcome Measures

Name	Time	Method
post-operative infection	within one month after operation	incidence of post-operative infection

Secondary Outcome Measures

Name	Time	Method
post-op complication	within one month after operation	intensity of pain, measured by VAS(visual analogue score)

Trial Locations

Locations (1)

Yi-Chia Chan; 🇨🇳 Kaohsiung, 鳥松區, Taiwan