NCT03295955

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2018

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

12 months

First QC Date

September 20, 2017

Last Update Submit

September 26, 2017

Conditions

Surgical Wound InfectionThyroid Nodule

Outcome Measures

Primary Outcomes (2)

  • "CDC 1992 SSI table" score

    Clinical evidence of Surgical Site Infection

    Postoperative 1 day

  • CBC, CRP

    Laboratory test

    Postoperative 1 day

Secondary Outcomes (2)

  • Change of "CDC 1992 SSI table" score

    Compare the CDC 1992 SSI table score between postoperative 1 day and 2 day/2 weeks.

  • Change of CBC, CRP

    Compare the CBC, CRP between postoperative 1 day and 2 day

Study Arms (2)

Postop antibiotics group

ACTIVE COMPARATOR

Prescribe Amoxicillin Clavulanate

Drug: Amoxicillin Clavulanate

No postop antibiotics

NO INTERVENTION

Do not prescribe Amoxicillin Clavulanate

Interventions

Amoxicillin ClavulanateDRUG

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

Postop antibiotics group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin Wook Yi

Seoul, 03080, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 28877292RESULT

  • 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.

    PMID: 26546193RESULT

  • 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.

    PMID: 31982170DERIVED

MeSH Terms

Conditions

Surgical Wound InfectionThyroid Nodule

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 28, 2017

Study Start

September 4, 2017

Primary Completion

September 3, 2018

Study Completion

December 3, 2018

Last Updated

September 28, 2017

Record last verified: 2017-09

Locations

KR(1)