Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 12:20 AM
Study NCT ID:
NCT07428057
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Hypocalcemia After Thyroidectomy
Sponsor:
Minia University
Organization:
Study Overview
Official Title:
A Ten-Year Cohort Study of Clinical and Surgical Predictors for Hypocalcemia Post-Thyroidectomy
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This retrospective cohort study investigates predictors of postoperative hypocalcemia following thyroidectomy procedures at Minia University Hospital over a 10-year period (2014-2024). Postthyroidectomy hypocalcemia is one of the most common complications of thyroid surgery, affecting 20-50% of patients. The study aims to identify demographic, clinical, laboratory, and surgical factors associated with the development of both transient and permanent hypocalcemia. Results will inform risk stratification, patient counseling, and perioperative management strategies.
Detailed Description:
Hypocalcemia is a frequent complication following thyroidectomy, resulting from inadvertent parathyroid gland injury, removal, or devascularization. While most cases resolve within 6 months (transient hypocalcemia),permanent hypocalcemia occurs in 1-3% of patients and requires lifelong calcium and vitamin D supplementation, significantly impacting quality of life.
This single-center retrospective study will systematically review medical records of all patients who underwent thyroidectomy (total, subtotal, or completion) at Minia University Hospital between January 1, 2014, andDecember 31, 2024. The primary objective is to identify independent predictors of postoperative hypocalcemia using multiple logistic regression analysis.
Data extraction will include:
Demographics: age, gender, BMI Clinical factors: indication for surgery, thyroid disease type, presence of Graves' disease, substernal extension Preoperative laboratory values: calcium, vitamin D, PTH, thyroid function tests Surgical details: extent of thyroidectomy, central/lateral lymph node dissection, surgeon experience,operative time, parathyroid gland identification and autotransplantation Postoperative data: calcium levels (24h, 48h, 1 week, 6 weeks, 3 months, 6 months), PTH levels,supplementation requirements Pathology: thyroid weight, presence of parathyroid tissue in specimen, thyroiditis, malignancy The study will employ robust statistical methods including univariate analysis to screen potential predictors and multiple logistic regression to identify independent risk factors. A clinical risk prediction score will be developed and internally validated using split-sample methodology. Subgroup analyses will examine differences between transient and permanent hypocalcemia and stratify results by extent of surgery and surgeon experience.
Target sample size of 500-600 patients was calculated using G\*Power to ensure adequate statistical power(\>80%) .
Findings will contribute to evidence-based perioperative protocols, improved patient selection for outpatient thyroidectomy, tailored monitoring strategies, and informed decision-making regarding prophylactic calcium supplementation.
This single-center retrospective study will systematically review medical records of all patients who underwent thyroidectomy (total, subtotal, or completion) at Minia University Hospital between January 1, 2014, andDecember 31, 2024. The primary objective is to identify independent predictors of postoperative hypocalcemia using multiple logistic regression analysis.
Data extraction will include:
Demographics: age, gender, BMI Clinical factors: indication for surgery, thyroid disease type, presence of Graves' disease, substernal extension Preoperative laboratory values: calcium, vitamin D, PTH, thyroid function tests Surgical details: extent of thyroidectomy, central/lateral lymph node dissection, surgeon experience,operative time, parathyroid gland identification and autotransplantation Postoperative data: calcium levels (24h, 48h, 1 week, 6 weeks, 3 months, 6 months), PTH levels,supplementation requirements Pathology: thyroid weight, presence of parathyroid tissue in specimen, thyroiditis, malignancy The study will employ robust statistical methods including univariate analysis to screen potential predictors and multiple logistic regression to identify independent risk factors. A clinical risk prediction score will be developed and internally validated using split-sample methodology. Subgroup analyses will examine differences between transient and permanent hypocalcemia and stratify results by extent of surgery and surgeon experience.
Target sample size of 500-600 patients was calculated using G\*Power to ensure adequate statistical power(\>80%) .
Findings will contribute to evidence-based perioperative protocols, improved patient selection for outpatient thyroidectomy, tailored monitoring strategies, and informed decision-making regarding prophylactic calcium supplementation.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: