HyperthyroidismNCT01095341
Postoperative Hyperthyroidism
An observational study of Hyperthyroidism, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the frequency and the clinical course of postoperative hyperthyroidism following surgery of tertiary hyperparathyroidism (THP) and to determine the diagnostic value of thyroglobulin in this setting. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hyperthyroidism
- How many people
- 57 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Apr 2009
- 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: patients with tertiary hyperparathyroidism undergoing surgery for this reason
Who may be able to join
- patients with tertiary hyperparathyroidism undergoing surgery for this reason
- dialysis treatment
Who cannot join
- patients wish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Hyperthyroidism After Parathyroidectomy
The purpose of this study is to evaluate the frequency and the clinical course of postoperative hyperthyroidism following surgery of tertiary hyperparathyroidism (THP) and to determine the diagnostic value of thyroglobulin in this setting.
- Conditions
- Hyperthyroidism
- Being tested
- No intervention performed
- Keywords
- hyperthyroidism, tertiary hyperparathyroidism, palpation thyroiditis, parathyroidectomy, thyroglobulin, rate of postoperative hyperthyroidism
- Medical subject headings
- Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention performedOther
| Study group | Role | What they receive |
|---|---|---|
| THP | THP: patients undergoing parathyroidectomy according to tertiary hyperparathyroidism Receives: Other: No intervention performed | |
| Other causes | patients with hyperthyroidism not caused by parathyroidectomy Receives: Other: No intervention performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperthyroidism
Secondary outcomes (1)
Thyroglobulin elevation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperthyroidismStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Gottfried Rudofsky, MD, Principal investigator, University Hospital Heidelberg Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095341
- Sponsor's protocol ID
- GR-2010
- Status last verified
- Mar 2010
- First submitted
- 29 Mar 2010
- Last updated
- 30 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Rudofsky G Jr, Grafe IA, Metzner C, Leowardi C, Fohr B. Transient post-operative thyrotoxicosis after parathyroidectomy. Med Sci Monit. 2009 Mar;15(3):CS41-3.
PubMed 19247247
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Hyperthyroidism After Parathyroidectomy
- ClinicalTrials.gov ID
- NCT01095341
- Acronym / sponsor ID
- GR-2010
- Conditions
- Hyperthyroidism
- Keywords
- hyperthyroidism, tertiary hyperparathyroidism, palpation thyroiditis, parathyroidectomy, thyroglobulin, rate of postoperative hyperthyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 30 Mar 2010 (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 purpose of this study is to evaluate the frequency and the clinical course of postoperative hyperthyroidism following surgery of tertiary hyperparathyroidism (THP) and to determine the diagnostic value of thyroglobulin in this setting.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THP | – | Other: No intervention performedTHP: patients undergoing parathyroidectomy according to tertiary hyperparathyroidism |
| Other causes | – | Other: No intervention performedpatients with hyperthyroidism not caused by parathyroidectomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with tertiary hyperparathyroidism undergoing surgery for this reason
Key inclusion criteria (2 listed)
- patients with tertiary hyperparathyroidism undergoing surgery for this reason
- dialysis treatment
Key exclusion criteria (1 listed)
- patients wish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention performed | Other | Other causes, THP |
Primary outcome
Hyperthyroidism
1 secondary outcome
Thyroglobulin elevation
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 30 Mar 2010.
- Background: PubMed 19247247Rudofsky G Jr, Grafe IA, Metzner C, Leowardi C, Fohr B. Transient post-operative thyrotoxicosis after parathyroidectomy. Med Sci Monit. 2009 Mar;15(3):CS41-3.
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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.
Gottfried Rudofsky, MD principal investigator
University Hospital Heidelberg Germany
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 Hyperthyroidism, run by Heidelberg University at 1 site in Germany.
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 30 Mar 2010. 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 Germany. 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?
Hyperthyroidism. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01095341, which also lists 1 linked publication.
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 30 Mar 2010.