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

Surgical Wound Infection Clinical Trial

— POTO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03295955
• Other study ID #: 1708-028-875
• Status: Recruiting
• Phase: N/A
• First received: September 20, 2017
• Last updated: September 26, 2017
• Start date: September 4, 2017
• Est. completion date: December 3, 2018

Study information

• Verified date: September 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 3, 2018
• Est. primary completion date: September 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound Infection
• Thyroid Nodule
• Wound Infection

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Jin Wook Yi	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Anuwong A, Ketwong K, Jitpratoom P, Sasanakietkul T, Duh QY. Safety and Outcomes of the Transoral Endoscopic Thyroidectomy Vestibular Approach. JAMA Surg. 2017 Sep 6. doi: 10.1001/jamasurg.2017.3366. [Epub ahead of print] — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"CDC 1992 SSI table" score	Clinical evidence of Surgical Site Infection	Postoperative 1 day
Primary	CBC, CRP	Laboratory test	Postoperative 1 day
Secondary	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.
Secondary	Change of CBC, CRP	Laboratory test	Compare the CBC, CRP between postoperative 1 day and 2 day