Clinical trial NCT03295955: Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy
Official title: Comparing Efficacy of Postoperative Antibiotic Use in Transoral Thyroidectomy: a Prospective Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Wound Infection
Thyroid Nodule
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: "CDC 1992 SSI table" score
timeFrame: Postoperative 1 day
measure: CBC, CRP
timeFrame: Postoperative 1 day
Secondary outcomes:
measure: Change of "CDC 1992 SSI table" score
timeFrame: Compare the CDC 1992 SSI table score between postoperative 1 day and 2 day/2 weeks.
measure: Change of CBC, CRP
timeFrame: Compare the CBC, CRP between postoperative 1 day and 2 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin Wook Yi
Study officials:
References:
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.
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.
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.