NCT07428057

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

March 4, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

February 17, 2026

Last Update Submit

June 27, 2026

Conditions

Keywords

ThyroidectomyPostoperative hypocalcemiaHypoparathyroidismParathyroid gland injuryTotal thyroidectomy

Outcome Measures

Primary Outcomes (1)

  • 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

    Within 6 months post-surgery

Secondary Outcomes (10)

  • Incidence of Transient Hypocalcemia

    Up to 6 months post-surgery

  • Incidence of Permanent Hypocalcemia

    6 months post-surgery

  • Incidence of Symptomatic Hypocalcemia

    Within 2 weeks post-surgery

  • Hospital Length of Stay

    From surgery to discharge, typically 2-5 days

  • Calcium and Vitamin D Supplementation Requirement

    Up to 6 months post-surgery

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University Hospital

Minya, Minya Governorate, 61519, Egypt

RECRUITING

Related Publications (3)

  • 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.

    PMID: 24402815BACKGROUND
  • Thomusch 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.

    PMID: 12605179BACKGROUND
  • Lorente-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.

    PMID: 25605285BACKGROUND

MeSH Terms

Conditions

Thyroid NoduleHypocalcemiaThyroid NeoplasmsPostoperative ComplicationsHypoparathyroidism

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte ImbalancePathologic ProcessesPathological Conditions, Signs and SymptomsParathyroid Diseases

Study Officials

  • Saleh K Saleh, MD

    Minia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 17, 2026

First Posted

February 23, 2026

Study Start

March 4, 2026

Primary Completion

July 1, 2026

Study Completion

August 1, 2026

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations