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

Primary Purpose

Surgical Wound Infection, Thyroid Nodule

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Amoxicillin Clavulanate
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound Infection

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jin Wook YiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Postop antibiotics group

No postop antibiotics

Arm Description

Prescribe Amoxicillin Clavulanate

Do not prescribe Amoxicillin Clavulanate

Outcomes

Primary Outcome Measures

"CDC 1992 SSI table" score
Clinical evidence of Surgical Site Infection
CBC, CRP
Laboratory test

Secondary Outcome Measures

Change of "CDC 1992 SSI table" score
Clinical evidence of Surgical Site Infection
Change of CBC, CRP
Laboratory test

Full Information

First Posted
September 20, 2017
Last Updated
September 26, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03295955
Brief Title
Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy
Acronym
POTO
Official Title
Comparing Efficacy of Postoperative Antibiotic Use in Transoral Thyroidectomy: a Prospective Randomized Controlled Trial Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
September 3, 2018 (Anticipated)
Study Completion Date
December 3, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection, Thyroid Nodule

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Postop antibiotics group
Arm Type
Active Comparator
Arm Description
Prescribe Amoxicillin Clavulanate
Arm Title
No postop antibiotics
Arm Type
No Intervention
Arm Description
Do not prescribe Amoxicillin Clavulanate
Intervention Type
Drug
Intervention Name(s)
Amoxicillin Clavulanate
Intervention Description
Per-oral "Amoxicillin Clavulanate" Given or Non-given, after surgery
Primary Outcome Measure Information:
Title
"CDC 1992 SSI table" score
Description
Clinical evidence of Surgical Site Infection
Time Frame
Postoperative 1 day
Title
CBC, CRP
Description
Laboratory test
Time Frame
Postoperative 1 day
Secondary Outcome Measure Information:
Title
Change of "CDC 1992 SSI table" score
Description
Clinical evidence of Surgical Site Infection
Time Frame
Compare the CDC 1992 SSI table score between postoperative 1 day and 2 day/2 weeks.
Title
Change of CBC, CRP
Description
Laboratory test
Time Frame
Compare the CBC, CRP between postoperative 1 day and 2 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Jin Wook Yi
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Wook Yi, MD, MS
Phone
+82-2-2072-3243
Email
gnsljw@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28877292
Citation
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.
Results Reference
result
PubMed Identifier
26546193
Citation
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.
Results Reference
result
PubMed Identifier
31982170
Citation
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.
Results Reference
derived

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

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