2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

Thyroid Nodule Clinical Trial

Official title:

2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04268407
• Other study ID #: 201902024A3
• Status: Completed
• Phase: N/A
• Start date: February 26, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2022
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Nodule

Intervention

Drug:
• Amoxicillin Clavulanate
compare the duration of antbiotic use: 2 day versus 7 day

Locations

Country	Name	City	State
Taiwan	Yi-Chia Chan	Kaohsiung	???

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View Citation

Fernandez-Ranvier G, Meknat A, Guevara DE, Inabnet WB 3rd. Transoral Endoscopic Thyroidectomy Vestibular Approach. JSLS. 2019 Oct-Dec;23(4). pii: e2019.00036. doi: 10.4293/JSLS.2019.00036. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	post-op complication	mental nerve injury, measured by patient description of chin numbness	within one month after operation
Other	post-op complication	skin thermal or penetrated injury, noted during operation	within one month after operation
Other	post-op complication	post-operative hypoparathyroidism, measured by post-operative serum intact PTH level	within one month after operation
Other	post-op complication	recurrent laryngeal nerve injury, measured by clinical symptom and proved by laryngoscope	within one month after operation
Primary	post-operative infection	incidence of post-operative infection	within one month after operation
Secondary	post-op complication	intensity of pain, measured by VAS(visual analogue score)	within one month after operation