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

NCT ID: NCT03295955

Last Updated: 2017-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-04

Study Completion Date

2018-12-03

Brief Summary

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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

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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.

Conditions

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Surgical Wound Infection Thyroid Nodule

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Postop antibiotics group

Prescribe Amoxicillin Clavulanate

Group Type ACTIVE_COMPARATOR

Amoxicillin Clavulanate

Intervention Type DRUG

Per-oral "Amoxicillin Clavulanate" Given or Non-given, after surgery

No postop antibiotics

Do not prescribe Amoxicillin Clavulanate

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Amoxicillin Clavulanate

Per-oral "Amoxicillin Clavulanate" Given or Non-given, after surgery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin Wook Yi

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jin Wook Yi

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Jin Wook Yi, MD, MS

Role: primary

[email protected]
+82-2-2072-3243

References

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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.

Reference Type RESULT
PMID: 28877292 (View on PubMed)

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.

Reference Type RESULT
PMID: 26546193 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31982170 (View on PubMed)

Other Identifiers

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1708-028-875

Identifier Type: -

Identifier Source: org_study_id