2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy
Primary Purpose
Thyroid Nodule
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Amoxicillin Clavulanate
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Nodule focused on measuring transoral surgery
Eligibility Criteria
Inclusion Criteria:
- Suspicious or proved thyroid cancer with size smaller than 4cm
- Symptomatic benign thyroid nodules less than 6cm in size
- Thyroid cyst
- Follicular neoplasm
- Graves' disease
Exclusion Criteria:
- Previous thyroid or parathyroid surgery
- History of radiation at neck
- Could not tolerate the general anesthesia.
Sites / Locations
- Yi-Chia Chan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
2-day prophylactic antibiotics
7-day prophylactic antibiotic
Arm Description
use prophylactic antibiotic for 2 days after transoral thyroidectomy
use prophylactic antibiotic for 7 days after transoral thyroidectomy
Outcomes
Primary Outcome Measures
post-operative infection
incidence of post-operative infection
Secondary Outcome Measures
post-op complication
intensity of pain, measured by VAS(visual analogue score)
Full Information
NCT ID
NCT04268407
First Posted
February 7, 2020
Last Updated
July 28, 2022
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04268407
Brief Title
2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy
Official Title
2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In transoral thyroidectomy via vestibular approach (TOETVA), prophylactic antibiotic for 5~7 days is recommended for the clean-contaminated wound. In this study, the investigators design a 2-day versus 7-day antibiotic prophylaxis to compare the surgical result and infection rate.
Detailed Description
Remote-access thyroid surgery has gained popularity and has advanced significantly over the past two decades, given the patient desire to avoid cosmetically displeasing scarring. The mostly recently introduced remote thyroid surgery is the transoral endoscopic thyroid surgery via vestibular approach (TOETVA). Because of the several advantages comparing with other removeaccess thyroid surgery, making it nowadays growing in popularity since 2016. However, TOETVA carry some inherent risks, including mental nerve injury, tumor seeding and local recurrence, fibrosis-induced long-lasting pulling sensation below the lower jaws, and surgical site infection coming from the clean-contaminated environment of oral incision.
Comparing with clean wound via the traditional open surgery, TOETVA carry the potential risk of infection. Based on the author's recommendation, prophylactic antibiotic (augmentin) will be administered 30 minutes before incision at operative room, followed by 2-day course of intravenous antibiotic, then shift to 5-day course of oral antibiotic finally. Up to date, only few case complicating postoperative infection were reported with extremely low infection rate (<1%). Therefore, the investigators want to study the short-course (2 days) of antibiotic coverage is also effective to prevent surgical site infection. It was proved in the preliminary study, comprising 5 patients in each group (2-day course in the study group and 7-day course in the control group). Later, the investigators will recruit more patients (n=100) to confirm this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule
Keywords
transoral surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
thyroid nodules, plan for transoral thyroidectomy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2-day prophylactic antibiotics
Arm Type
Experimental
Arm Description
use prophylactic antibiotic for 2 days after transoral thyroidectomy
Arm Title
7-day prophylactic antibiotic
Arm Type
Other
Arm Description
use prophylactic antibiotic for 7 days after transoral thyroidectomy
Intervention Type
Drug
Intervention Name(s)
Amoxicillin Clavulanate
Other Intervention Name(s)
Augmentin
Intervention Description
compare the duration of antbiotic use: 2 day versus 7 day
Primary Outcome Measure Information:
Title
post-operative infection
Description
incidence of post-operative infection
Time Frame
within one month after operation
Secondary Outcome Measure Information:
Title
post-op complication
Description
intensity of pain, measured by VAS(visual analogue score)
Time Frame
within one month after operation
Other Pre-specified Outcome Measures:
Title
post-op complication
Description
mental nerve injury, measured by patient description of chin numbness
Time Frame
within one month after operation
Title
post-op complication
Description
skin thermal or penetrated injury, noted during operation
Time Frame
within one month after operation
Title
post-op complication
Description
post-operative hypoparathyroidism, measured by post-operative serum intact PTH level
Time Frame
within one month after operation
Title
post-op complication
Description
recurrent laryngeal nerve injury, measured by clinical symptom and proved by laryngoscope
Time Frame
within one month after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suspicious or proved thyroid cancer with size smaller than 4cm
Symptomatic benign thyroid nodules less than 6cm in size
Thyroid cyst
Follicular neoplasm
Graves' disease
Exclusion Criteria:
Previous thyroid or parathyroid surgery
History of radiation at neck
Could not tolerate the general anesthesia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yichia Chan, doctor
Organizational Affiliation
Kaohsing Chang Gung memorial hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yi-Chia Chan
City
Kaohsiung
State/Province
鳥松區
ZIP/Postal Code
833
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
only for request
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
background
PubMed Identifier
31719772
Citation
Fernandez-Ranvier G, Meknat A, Guevara DE, Inabnet WB 3rd. Transoral Endoscopic Thyroidectomy Vestibular Approach. JSLS. 2019 Oct-Dec;23(4):e2019.00036. doi: 10.4293/JSLS.2019.00036.
Results Reference
background
PubMed Identifier
23890962
Citation
Wang C, Zhai H, Liu W, Li J, Yang J, Hu Y, Huang J, Yang W, Pan Y, Ding H. Thyroidectomy: a novel endoscopic oral vestibular approach. Surgery. 2014 Jan;155(1):33-8. doi: 10.1016/j.surg.2013.06.010. Epub 2013 Jul 24.
Results Reference
background
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2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy
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