2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Nodule
• Intervention / Treatment: Drug: Amoxicillin Clavulanate

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • 鳥松區
    • Kaohsiung, 鳥松區, Taiwan, 833
      • Yi-Chia Chan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-op complication	mental nerve injury, measured by patient description of chin numbness	within one month after operation
post-op complication	skin thermal or penetrated injury, noted during operation	within one month after operation
post-op complication	post-operative hypoparathyroidism, measured by post-operative serum intact PTH level	within one month after operation
post-op complication	recurrent laryngeal nerve injury, measured by clinical symptom and proved by laryngoscope	within one month after operation

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Yichia Chan, doctor, Kaohsing Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• Anuwong A, Ketwong K, Jitpratoom P, Sasanakietkul T, Duh QY. Safety and Outcomes of the Transoral Endoscopic Thyroidectomy Vestibular Approach. JAMA Surg. 2018 Jan 1;153(1):21-27. doi: 10.1001/jamasurg.2017.3366.
• Fernandez-Ranvier G, Meknat A, Guevara DE, Inabnet WB 3rd. Transoral Endoscopic Thyroidectomy Vestibular Approach. JSLS. 2019 Oct-Dec;23(4):e2019.00036. doi: 10.4293/JSLS.2019.00036.
• Wang C, Zhai H, Liu W, Li J, Yang J, Hu Y, Huang J, Yang W, Pan Y, Ding H. Thyroidectomy: a novel endoscopic oral vestibular approach. Surgery. 2014 Jan;155(1):33-8. doi: 10.1016/j.surg.2013.06.010. Epub 2013 Jul 24.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: transoral surgery
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Nodule; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: 201902024A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: only for request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No