Thyroid Nodule
Conditions
Keywords
transoral surgery
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.
Interventions
compare the duration of antbiotic use: 2 day versus 7 day
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
thyroid nodules, plan for transoral thyroidectomy
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post-operative infection | within one month after operation | incidence of post-operative infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| post-op complication | within one month after operation | intensity of pain, measured by VAS(visual analogue score) |
Other
| Measure | Time frame | Description |
|---|---|---|
| post-op complication | within one month after operation | mental nerve injury, measured by patient description of chin numbness |
Countries
Taiwan
Outcome results
None listed