Clinical trial NCT04268407: 2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy
Official title: 2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Nodule
Keywords: transoral surgery
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: thyroid nodules, plan for transoral thyroidectomy
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: post-operative infection
timeFrame: within one month after operation
Secondary outcomes:
measure: post-op complication
timeFrame: within one month after operation
Other outcomes:
measure: post-op complication
timeFrame: within one month after operation
measure: post-op complication
timeFrame: within one month after operation
measure: post-op complication
timeFrame: within one month after operation
measure: post-op complication
timeFrame: within one month after operation
Locations:
city: Kaohsiung
country: Taiwan
facility: Yi-Chia Chan
state: 鳥松區
Study officials:
affiliation: Kaohsing Chang Gung memorial hospital
name: Yichia Chan, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.