2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedStudy Start
First participant enrolled
February 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedAugust 1, 2022
July 1, 2022
1.8 years
February 7, 2020
July 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
post-operative infection
incidence of post-operative infection
within one month after operation
Secondary Outcomes (1)
post-op complication
within one month after operation
Other Outcomes (4)
post-op complication
within one month after operation
post-op complication
within one month after operation
post-op complication
within one month after operation
- +1 more other outcomes
Study Arms (2)
2-day prophylactic antibiotics
EXPERIMENTALuse prophylactic antibiotic for 2 days after transoral thyroidectomy
7-day prophylactic antibiotic
OTHERuse prophylactic antibiotic for 7 days after transoral thyroidectomy
Interventions
compare the duration of antbiotic use: 2 day versus 7 day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous thyroid or parathyroid surgery
- History of radiation at neck
- Could not tolerate the general anesthesia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yi-Chia Chan
Kaohsiung City, 鳥松區, 833, Taiwan
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: 28877292BACKGROUNDFernandez-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.
PMID: 31719772BACKGROUNDWang 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.
PMID: 23890962BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yichia Chan, doctor
Kaohsing Chang Gung memorial hospital
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
- principal investigator
Study Record Dates
First Submitted
February 7, 2020
First Posted
February 13, 2020
Study Start
February 26, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
August 1, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share
only for request