- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03031639
Khon Kaen University's Thyroidectomy Registry
February 17, 2021 updated by: Patorn Piromchai, Khon Kaen University
The endoscopic thyroidectomy approach is gaining popularity in the surgical field.
This registry tries to collect the outcomes including quality of life and complication for both endoscopic and conventional thyroidectomy methods.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
98
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Khonkaen
-
Muang, Khonkaen, Thailand, 40002
- Department of Otolaryngology, Khonkaen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The patients who underwent thyroidectomy at Khon Kaen University
Description
Inclusion Criteria:
- The patients who underwent thyroidectomy at Khon Kaen University
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Endoscopic
This group is the patients who underwent endoscopic approaches thyroidectomy.
|
Thyroid surgery using endoscopy.
|
|
Conventional
This group is the patients who underwent conventional approach thyroidectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline of QOL Score at 6 months
Time Frame: 6 months
|
Validated quality of life score(SF-36) will be measure at baseline and 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of the symptoms score
Time Frame: At 2, 6, 12, and 24 weeks after surgery
|
The questionnaire for pain, numbness, voice, swallowing and neck movement function will be given and the patient needs to rate from 0 to 10.
|
At 2, 6, 12, and 24 weeks after surgery
|
|
Complication rate
Time Frame: At 2, 6, 12, and 24 weeks after surgery
|
Complications after surgery
|
At 2, 6, 12, and 24 weeks after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Patorn Piromchai, MD, MSc, PhD, Khon Kaen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Piromchai P, Vatanasapt P, Reechaipichitkul W, Phuttharak W, Thanaviratananich S. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study. BMC Ear Nose Throat Disord. 2008 Mar 20;8:1. doi: 10.1186/1472-6815-8-1.
- Piromchai P, Wijakkanalan P, Teeramatwanich W, Kasemsiri P, Laohasiriwong S, Ratanaanekchai T. Postauricular-submental approach endoscopic thyroidectomy. Clin Otolaryngol. 2018 Apr;43(2):767-769. doi: 10.1111/coa.12791. Epub 2016 Nov 27. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 13, 2017
Primary Completion (Actual)
January 12, 2021
Study Completion (Actual)
January 12, 2021
Study Registration Dates
First Submitted
January 20, 2017
First Submitted That Met QC Criteria
January 24, 2017
First Posted (Estimate)
January 25, 2017
Study Record Updates
Last Update Posted (Actual)
February 18, 2021
Last Update Submitted That Met QC Criteria
February 17, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE591517
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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