Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy

Not Applicable

• Conditions: Surgical Wound Infection; Thyroid Nodule
• Interventions: Drug: Amoxicillin Clavulanate

• Registration Number: NCT03295955
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2017-09
• Study Start: 2017-09-04
• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-26
• Last Update Submitted: 2017-09-26
• Study First Posted: 2017-09-28
• Last Update Posted: 2017-09-28
• Primary Completion: 2018-09-03
• Study Completion: 2018-12-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postop antibiotics group	Amoxicillin Clavulanate	Prescribe Amoxicillin Clavulanate

Primary Outcome Measures

Name	Time	Method
CBC, CRP	Postoperative 1 day	Laboratory test
"CDC 1992 SSI table" score	Postoperative 1 day	Clinical evidence of Surgical Site Infection

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jin Wook Yi; 🇰🇷 Seoul, Korea, Republic of