Yi-Chia Chan
Kaohsiung City, 鳥松區, 833, Taiwan
NCT Number: NCT04268407
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.
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Notify Me20 year–80 year
All sexes
Interventional
Not applicable
Kaohsiung City, 鳥松區, 833, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
compare the duration of antbiotic use: 2 day versus 7 day
Other names: Augmentin
Time frame: within one month after operation
incidence of post-operative infection
Time frame: within one month after operation
intensity of pain, measured by VAS(visual analogue score)
Time frame: within one month after operation
mental nerve injury, measured by patient description of chin numbness
Time frame: within one month after operation
skin thermal or penetrated injury, noted during operation
Time frame: within one month after operation
post-operative hypoparathyroidism, measured by post-operative serum intact PTH level
Time frame: within one month after operation
recurrent laryngeal nerve injury, measured by clinical symptom and proved by laryngoscope
Chang Gung Memorial Hospital
Other
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