- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07701824
Ionized Calcium Changes for Predicting Postoperative Hypocalcemia After Total Thyroidectomy
Predictive Value of Preoperative, Intraoperative, and Postoperative Ionized Calcium Changes Measured by Blood Gas Analysis for Postoperative Hypocalcemia After Total Thyroidectomy
Study Overview
Status
Intervention / Treatment
Detailed Description
Postoperative hypocalcemia is a common complication after total thyroidectomy and may be associated with changes in calcium homeostasis and parathyroid function. Early identification of patients at risk for postoperative hypocalcemia may help guide postoperative monitoring and calcium replacement strategies.
This prospective observational study included patients who underwent total thyroidectomy. Ionized calcium levels were measured by blood gas analysis at predefined perioperative time points, including the preoperative, intraoperative, and postoperative periods. Serum parathyroid hormone levels were also recorded. The study evaluated the relationship between perioperative changes in ionized calcium levels, postoperative parathyroid hormone changes, and the development of postoperative hypocalcemia.
The primary objective was to determine whether perioperative ionized calcium changes can predict postoperative hypocalcemia after total thyroidectomy. Secondary objectives included evaluating the association between postoperative parathyroid hormone changes and postoperative hypocalcemia and assessing the diagnostic performance of ionized calcium measurements for predicting hypocalcemia.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Başakşehir, Turkey (Türkiye)
- Başakşehir Çam and Sakura City Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 to 75 years
- Present to the General Surgery Clinic of Başakşehir Çam and Sakura City Hospital
- Diagnosis of thyroid disorders according to ICD code E07
- Scheduled to undergo total thyroidectomy due to toxic multinodular goiter, multinodular goiter, or papillary carcinoma
- Provide informed consent to participate in the study.
Exclusion Criteria:
- Patients with preoperative parathyroid disorders associated hypocalcemia or hypercalcemia.
- Patients with a history of previous thyroidectomy
- Patients with a history of previous parathyroidectomy
- Patients with a history of previous neck surgery.
- Patients with chronic kidney disease.
- Patients with a history of non-thyroid malignancy.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
total thyroidectomy patients
|
Ionized calcium levels will be measured by blood gas analysis at predefined preoperative, intraoperative, and postoperative time points in patients undergoing total thyroidectomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ionized calcium
Time Frame: Preoperative baseline; postoperative 10 minutes; postoperative 6 hours
|
Ionized calcium levels will be measured by blood gas analysis at predefined preoperative and postoperative time points in patients undergoing total thyroidectomy.
|
Preoperative baseline; postoperative 10 minutes; postoperative 6 hours
|
|
parathormone levels
Time Frame: Preoperative baseline; postoperative 10 minutes; postoperative 6 hours; and postoperative 6 months
|
Serum parathyroid hormone levels will be measured in patients undergoing total thyroidectomy to evaluate the association between postoperative parathyroid hormone changes and postoperative hypocalcemia.
|
Preoperative baseline; postoperative 10 minutes; postoperative 6 hours; and postoperative 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAEK-11/12.03.2025.87
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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