Skip to content

Early Prediction of Hypocalcaemia Following Thyroid Surgery

Early Prediction of Hypocalcaemia Following Thyroid Surgery: A Prospective Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02853721
Enrollment
150
Registered
2016-08-03
Start date
2014-01-31
Completion date
2015-04-30
Last updated
2016-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypocalcemia

Brief summary

150 patients divided into two groups.The experimental group was submitted at the assay of iPTH six hours after surgery whilst the control group was submitted to a daily assay of serum calcium and phosphorus.

Detailed description

Purpose: The aim of this randomized controlled trial was to validate the results of a previous prospective cohort study conducted in the same surgical unit regarding the use of concomitant intact parathyroid hormone (iPTH) and serum calcium measurement in predicting hypocalcemia after total thyroidectomy. Methods: From January 2014 to January 2015, 150 patients underwent total thyroidectomy in our department and were divided into two groups. The experimental group was submitted at the assay of iPTH six hours after surgery whilst the control group was submitted to a daily assay of serum calcium and phosphorus. Sensitivity and specificity of different serum measurements have been calculated using the Receiver-operator characteristics (ROC) curve.

Interventions

OTHERiPTH

iPTH assay six hours after surgery

OTHERno dosage of iPTH

Ca and P on postoperative day 1 and 2

Sponsors

University of Cagliari
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Be submitted to total thyroidectomy during the study period * Have signed the informed consent

Exclusion criteria

* Lack of inclusion criteria * Lobectomy with isthmusectomy or partial or subtotal thyroidectomy * Completion thyroidectomy * Concomitant hyperparathyroidism was present * Concomitant treatment with oral calcium and/or vitamin D prior to surgery

Design outcomes

Primary

MeasureTime frameDescription
Sensibility and specificity of iPTH and serum calcium measurement1 monthSensitivity and specificity of serum measurement using the Receiver-operator characteristics (ROC) curve

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026