Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy (POTO)

Comparing Efficacy of Postoperative Antibiotic Use in Transoral Thyroidectomy: a Prospective Randomized Controlled Trial Study

Transoral endoscopic thyroid surgery is a emerging surgical technique for thyroid surgery. This study to investigate the need for postoperative antibiotics in transoral endoscopic thyroid surgery.

Study Overview

• Status: Unknown
• Conditions: Surgical Wound Infection; Thyroid Nodule
• Intervention / Treatment: Drug: Amoxicillin Clavulanate

Detailed Description

To prevent possible infection from the oral cavity flora, most surgeons prescribe postoperative oral antibiotics more than 3 to 7 days after surgery. Currently, there's no clinical evidence that postoperative oral antibiotics is necessary or not in transoral endoscopic thyroid surgery. The investigator will conduct randomization after transoral thyroid surgery with two groups : postoperative oral antibiotics group versus no oral antibiotics group.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Jin Wook Yi
    • Contact: Jin Wook Yi, MD, MS; Phone Number: +82-2-2072-3243; Email: gnsljw@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who planned to Transoral endoscopic thyroidectomy
• Age between 20 to 70
• Voluntarily consenting to the study and study agreement
• No local invasion or distant metastasis
• Normal vocal cord function in laryngoscopic exam
• No significant abnormalities in preoperative laboratory tests

Exclusion Criteria:

• Take aspirin or antiplatelet drugs within 7 days before admission
• Uncontrolled hypertension, diabetes, chronic renal failure, or coagulation disease
• History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack)
• Substance abuse and alcohol abuse
• History of esophageal and airway diseases
• Patient was participated in other clinical trials within 30 days
• History of neck irradiation or surgery
• History of drug allergies
• Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Postop antibiotics group; Prescribe Amoxicillin Clavulanate	Drug: Amoxicillin Clavulanate; Per-oral "Amoxicillin Clavulanate" Given or Non-given, after surgery
No Intervention: No postop antibiotics; Do not prescribe Amoxicillin Clavulanate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"CDC 1992 SSI table" score	Clinical evidence of Surgical Site Infection	Postoperative 1 day
CBC, CRP	Laboratory test	Postoperative 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of "CDC 1992 SSI table" score	Clinical evidence of Surgical Site Infection	Compare the CDC 1992 SSI table score between postoperative 1 day and 2 day/2 weeks.
Change of CBC, CRP	Laboratory test	Compare the CBC, CRP between postoperative 1 day and 2 day

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• Anuwong A. Transoral Endoscopic Thyroidectomy Vestibular Approach: A Series of the First 60 Human Cases. World J Surg. 2016 Mar;40(3):491-7. doi: 10.1007/s00268-015-3320-1.
• 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.
• Yi JW, Kim SJ, Lee KE. Evaluation of the efficacy of postoperative antibiotic treatment in transoral endoscopic thyroidectomy: a prospective randomised controlled trial. Br J Oral Maxillofac Surg. 2020 Apr;58(3):334-340. doi: 10.1016/j.bjoms.2020.01.004. Epub 2020 Jan 22.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2017
• Primary Completion (Anticipated): September 3, 2018
• Study Completion (Anticipated): December 3, 2018

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2017
• Last Update Submitted That Met QC Criteria: September 26, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Neoplasms; Neoplasms by Site; Postoperative Complications; Wounds and Injuries; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms; Surgical Wound; Surgical Wound Infection; Wound Infection; Thyroid Nodule; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: 1708-028-875

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No