Thyroid DiseaseNCT01539499
Complications of Endocrine Surgery: Data From the United HealthSystem Consortium
An observational study of Thyroid Disease and Parathyroid Disease, run by University of Arkansas at 1 site in United States.
Trial summary
The goal of this study is to help better determine the complication rates for endocrine surgery across the nation for both benign and malignant disease. It is our hypothesis that the complication rates are low overall and that malignant disease results in a higher complication rate than benign disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Thyroid Disease, Parathyroid Disease, Endocrine Gland
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted through a United HealthSystem Consortium query of endocrine surgery done as a primary procedure for specific diagnosis.
Who may be able to join
- All patients between the ages of 18 and 90 years who have a diagnosis of benign multinodular goiter and/or malignant thyroid disease and have undergone a total thyroidectomy as a primary procedure.
- Parathyroid patients will also be studied.
Who cannot join
- Non endocrine surgery patients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Complications of Endocrine Surgery: Data From the United Health System Consortium
The goal of this study is to help better determine the complication rates for endocrine surgery across the nation for both benign and malignant disease. It is our hypothesis that the complication rates are low overall and that malignant disease results in a higher complication rate than benign disease. This study will do a database review from all University HealthSystem Consortium (UHC).
- Conditions
- Thyroid Disease, Parathyroid Disease, Endocrine Gland
- Medical subject headings
- Thyroid Diseases, Parathyroid Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Rates for Endocrine Surgery
The information presented in this report will provide a surgical tool for otolaryngologists to safely inform patients on the risks of endocrine surgery.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startJan 2010
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseaseStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brendan Stack, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539499
- Sponsor's protocol ID
- 112685
- Status last verified
- Aug 2017
- First submitted
- 21 Feb 2012
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications of Endocrine Surgery: Data From the United Health System Consortium
- ClinicalTrials.gov ID
- NCT01539499
- Acronym / sponsor ID
- 112685
- Conditions
- Thyroid Disease, Parathyroid Disease, Endocrine Gland
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to help better determine the complication rates for endocrine surgery across the nation for both benign and malignant disease. It is our hypothesis that the complication rates are low overall and that malignant disease results in a higher complication rate than benign disease. This study will do a database review from all University HealthSystem Consortium (UHC).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted through a United HealthSystem Consortium query of endocrine surgery done as a primary procedure for specific diagnosis.
Key inclusion criteria (2 listed)
- All patients between the ages of 18 and 90 years who have a diagnosis of benign multinodular goiter and/or malignant thyroid disease and have undergone a total thyroidectomy as a primary procedure.
- Parathyroid patients will also be studied.
Key exclusion criteria (1 listed)
- Non endocrine surgery patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complication Rates for Endocrine Surgery
Time frame: baseline
The information presented in this report will provide a surgical tool for otolaryngologists to safely inform patients on the risks of endocrine surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brendan Stack, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Disease and Parathyroid Disease, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication Rates for Endocrine Surgery (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.