Hypocalcemia, Postoperative ParathormoneNCT03717116
Early Prediction of Hypocalcemia After Thyroidectomy Using Postoperative Second Hour Parathormone
An observational study of Hypocalcemia, Postoperative Parathormone, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Hypocalcemia is the most frequent complication in thyroid surgeries. Diagnosing this complication earlier will reduce longer hospital stay and will lead to an earlier intervention. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypocalcemia, Postoperative Parathormone
- What is being tested?
- parathormone level
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 1 Dec 2018
- How long will I take part?
- 12 Months
- 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 20 to 80 years
- All sexes
- Adult, Older adult
Study population: all patients with multinodular goiter, Graves, fine needle aspiartion biopsy with Bethesda 3-4 undergoing total thyroidectomy
Who may be able to join
- patients with multinodular goiter, Graves, fine needle aspiartion biopsy with Bethesda 3-4 undergoing total thyroidectomy
Who cannot join
- pregnant women
- patients with thyroid cancer or previous neck dissection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University
Istanbul, 34158
selen soylu, MD, 5375653811
About this study
Hypocalcemia is the most frequent complication in thyroid surgeries. Diagnosing this complication earlier will reduce longer hospital stay and will lead to an earlier intervention. The purpose of the study is to evaluate postoperative second hour parathyroid hormone measurement as a predictor for early stage hypocalcemia.
- Conditions
- Hypocalcemia, Postoperative Parathormone
- Being tested
- parathormone level
- Keywords
- hypocalcemia, parathormone, bone density
- Medical subject headings
- Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parathormone levelDiagnostic test
Also called calcium level
From the patients, blood will be taken preoperatively and postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| control-normocalcemia group | Not described Receives: Diagnostic Test: parathormone level | |
| hypocalcemia group | Not described Receives: Diagnostic Test: parathormone level |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative parathormone level
Measured: postoperative 2. hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Sep 2017
- Primary completion31 Oct 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypocalcemia, Postoperative ParathormoneStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selen Soylu, MD, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717116
- Sponsor's protocol ID
- 83045809-604.01.02, A-01
- Status last verified
- Oct 2018
- First submitted
- 22 Oct 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction of Hypocalcemia After Thyroidectomy Using Postoperative Second Hour Parathormone
- ClinicalTrials.gov ID
- NCT03717116
- Acronym / sponsor ID
- 83045809-604.01.02, A-01
- Conditions
- Hypocalcemia, Postoperative Parathormone
- Keywords
- hypocalcemia, parathormone, bone density
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 24 Oct 2018 (actual)
- 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.
Hypocalcemia is the most frequent complication in thyroid surgeries. Diagnosing this complication earlier will reduce longer hospital stay and will lead to an earlier intervention. The purpose of the study is to evaluate postoperative second hour parathyroid hormone measurement as a predictor for early stage hypocalcemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control-normocalcemia group | – | Diagnostic Test: parathormone level |
| hypocalcemia group | – | Diagnostic Test: parathormone level |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all patients with multinodular goiter, Graves, fine needle aspiartion biopsy with Bethesda 3-4 undergoing total thyroidectomy
Key inclusion criteria (1 listed)
- patients with multinodular goiter, Graves, fine needle aspiartion biopsy with Bethesda 3-4 undergoing total thyroidectomy
Key exclusion criteria (2 listed)
- pregnant women
- patients with thyroid cancer or previous neck dissection
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 |
|---|---|---|
| parathormone levelAlso: calcium levelFrom the patients, blood will be taken preoperatively and postoperatively. | Diagnostic test | control-normocalcemia group, hypocalcemia group |
Primary outcome
postoperative parathormone level
Time frame: postoperative 2. hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Hypocalcemia, Postoperative Parathormone
RecruitingObservational study
Postoperative Hypocalcemia After Thyroidectomy
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Not yet recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Recruiting
Comparing PTeye-assisted Versus Conventional Total Thyroidectomy
Hypocalcemia, Parathyroid
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.
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 Hypocalcemia, Postoperative Parathormone, run by Istanbul University at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Oct 2018. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact selen soylu (+905375653811, selen_soylu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative parathormone level (time frame: postoperative 2. hour). 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 24 Oct 2018.