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Spots Global Cancer Trial Database for 2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

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Trial Identification

Brief Title: 2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

Official Title: 2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

Study ID: NCT04268407

Conditions

Thyroid Nodule

Study Description

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

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Yi-Chia Chan, Kaohsiung, 鳥松區, Taiwan

Contact Details

Name: Yichia Chan, doctor

Affiliation: Kaohsing Chang Gung memorial hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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