Thyroid NoduleNCT07428057
Postoperative Hypocalcemia After Thyroidectomy
An observational study of Thyroid Nodule and Thyroid Dysfunction, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Nodule, Thyroid Dysfunction, Hypocalcemia
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2014to 1 Jan 2027
- Phase
- Observational
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective cohort study will include adult patients (aged 18 years and older) who underwent a thyroidectomy procedure at Minia University Hospital, a tertiary care centre in Egypt, between January 1, 2014, and December 31, 2024. The target population consists of approximately 600 consecutive patients who meet the eligibility criteria. This includes patients with available medical records containing complete surgical and postoperative data, documented postoperative serum calcium levels, and a minimum of 6 months of follow-up or a documented outcome status. Patients will be excluded if they have preoperative hypocalcemia, pre-existing parathyroid disorders, chronic kidney disease (Stage 3 or higher), or other conditions that significantly affect calcium metabolism. The study population represents a consecutive sample of all patients meeting these criteria over the 10-year study period at this single academic center.
Who may be able to join
- Adult patients aged 18 years or older at time of surgery
- Underwent thyroidectomy at Minia University Hospital
- Availability of medical records with complete surgical and postoperative data
- Documented serum calcium levels measured postoperatively
- Minimum follow-up of 6 months postoperatively or documented outcome status
Who cannot join
- Age less than 18 years at time of surgery
- Preoperative hypocalcemia (serum calcium <8.0 mg/dL or ionized calcium <1.0 mmol/L)
- Pre-existing parathyroid disorders (primary hyperparathyroidism, hypoparathyroidism, secondary or tertiary hyperparathyroidism)
- Chronic kidney disease Stage 3 or higher (estimated glomerular filtration rate <60 mL/min/1.73m²)
- Malabsorption syndromes affecting calcium metabolism (celiac disease, inflammatory bowel disease,short bowel syndrome)
- Concurrent planned parathyroidectomy
Show all 10Show fewer
- History of neck irradiation
- Chronic use of medications significantly affecting calcium metabolism (bisphosphonates, denosumab,cinacalcet, chronic corticosteroids)
- Incomplete medical records lacking essential data including surgical details, postoperative calcium levels,or follow-up data
- Patients lost to follow-up before 6-month endpoint without documented outcome status
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Minia University Hospital
Minya, Minya Governorate, 61519
Saleh K Saleh, MD, 01201765401 ext. +2, salehkhairy@mu.edu.eg
salehkhairy@mu.edu.eg
About this study
Official title: A Ten-Year Cohort Study of Clinical and Surgical Predictors for Hypocalcemia Post-Thyroidectomy
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.
Read the 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.
- Conditions
- Thyroid Nodule, Thyroid Dysfunction, Hypocalcemia, Thyroid Cancer, Postoperative Complications
- Keywords
- Thyroidectomy, Postoperative hypocalcemia, Hypoparathyroidism, Parathyroid gland injury, Total thyroidectomy
- Medical subject headings
- Thyroid Nodule, Hypocalcemia, Thyroid Neoplasms, Postoperative Complications, Hypoparathyroidism
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Hypocalcemia
Development of hypocalcemia defined as:
Serum total calcium <8.0 mg/dL (2.0 mmol/L) OR Ionized calcium <1.0 mmol/L OR Symptomatic hypocalcemia (perioral numbness, paresthesias, carpopedal spasm, positive Chvostek's orTrousseau's sign) requiring calcium supplementation Measured at: 24 hours, 48 hours, 1 week, 6 weeks, 3 months, and 6 months postoperatively
Measured: Within 6 months post-surgery
Secondary outcomes (10)
Incidence of Transient Hypocalcemia
Hypocalcemia that resolves within 6 months of surgery without need for continued calcium and/or vitamin D supplementation beyond 6-month follow-up
Measured: Up to 6 months post-surgery
Incidence of Permanent Hypocalcemia
Hypocalcemia requiring ongoing calcium and/or vitamin D supplementation persisting beyond 6months postoperatively, indicating permanent hypoparathyroidism
Measured: 6 months post-surgery
Incidence of Symptomatic Hypocalcemia
Clinical manifestations of hypocalcemia including:
Neuromuscular irritability (perioral tingling, paresthesias) Tetany or carpopedal spasm Positive Chvostek's sign (facial nerve twitching) Positive Trousseau's sign (carpal spasm with blood pressure cuff inflation) Seizures (rare) Cardiac manifestations: prolonged QT interval, arrhythmias (rare)
Measured: Within 2 weeks post-surgery
Hospital Length of Stay
Duration of hospitalization in days following thyroidectomy, measured from date of surgery to date of hospital discharge
Measured: From surgery to discharge, typically 2-5 days
Calcium and Vitamin D Supplementation Requirement
Need for oral calcium supplementation (yes/no and total daily dose in mg) Need for vitamin D supplementation (yes/no and total daily dose in IU) Duration of supplementation (days/weeks) Need for intravenous calcium administration (yes/no)
Measured: Up to 6 months post-surgery
Emergency Department Visits for Hypocalcemia
Unplanned emergency department visits related to symptoms of hypocalcemia or complications of calcium/vitamin D therapy
Measured: Within 30 days post-discharge
Hospital Readmission Related to Hypocalcemia
Unplanned hospital readmission related to symptomatic hypocalcemia or its complications
Measured: Within 30 days post-discharge
Postoperative Parathyroid Hormone (PTH) Level
Serum intact parathyroid hormone level measured within 24 hours postoperatively (pg/mL), used as predictor of sustained hypocalcemia
Measured: 24 hours post-surgery
Nadir Calcium Level
Lowest serum calcium level (total or ionized) recorded during initial hospitalization or within first week postoperatively
Measured: Within 7 days post-surgery
Time to Calcium Normalization
Duration in days from surgery to sustained normalization of serum calcium levels without supplementation (for those who develop hypocalcemia)
Measured: Up to 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Jan 2014
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies 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
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saleh Khairy Saleh MD, Minia University
- Investigators
- Saleh K Saleh, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428057
- Sponsor's protocol ID
- 1878/02/2026
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9.
PubMed 24402815Thomusch O, Machens A, Sekulla C, Ukkat J, Brauckhoff M, Dralle H. The impact of surgical technique on postoperative hypoparathyroidism in bilateral thyroid surgery: a multivariate analysis of 5846 consecutive patients. Surgery. 2003 Feb;133(2):180-5. doi: 10.1067/msy.2003.61.
PubMed 12605179Lorente-Poch L, Sancho JJ, Ruiz S, Sitges-Serra A. Importance of in situ preservation of parathyroid glands during total thyroidectomy. Br J Surg. 2015 Mar;102(4):359-67. doi: 10.1002/bjs.9676. Epub 2015 Jan 20.
PubMed 25605285