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Completed

NCT Number: NCT04268407

2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

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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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yi-Chia Chan

Kaohsiung City, 鳥松區, 833, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspicious or proved thyroid cancer with size smaller than 4cm
  • Symptomatic benign thyroid nodules less than 6cm in size
  • Thyroid cyst
  • Follicular neoplasm
  • Graves' disease

Exclusion criteria

  • Previous thyroid or parathyroid surgery
  • History of radiation at neck
  • Could not tolerate the general anesthesia.

Treatment and study plan

amoxicillin clavulanate

Drug

compare the duration of antbiotic use: 2 day versus 7 day

Other names: Augmentin

Primary outcomes

  1. post-operative infection

    Time frame: within one month after operation

    incidence of post-operative infection

Secondary outcomes

  1. post-op complication

    Time frame: within one month after operation

    intensity of pain, measured by VAS(visual analogue score)

Other outcomes

  1. post-op complication

    Time frame: within one month after operation

    mental nerve injury, measured by patient description of chin numbness

  2. post-op complication

    Time frame: within one month after operation

    skin thermal or penetrated injury, noted during operation

  3. post-op complication

    Time frame: within one month after operation

    post-operative hypoparathyroidism, measured by post-operative serum intact PTH level

  4. post-op complication

    Time frame: within one month after operation

    recurrent laryngeal nerve injury, measured by clinical symptom and proved by laryngoscope

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 13, 2020
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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