Early Prediction of Hypocalcaemia Following Thyroid Surgery

Not Applicable

Completed

• Conditions: Hypocalcemia
• Interventions: Other: no dosage of iPTH; Other: iPTH

• Registration Number: NCT02853721
• Lead Sponsor: University of Cagliari

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-01
• Study Completion: 2015-04
• Study First Submitted: 2016-05-06
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-29
• Last Update Submitted: 2016-07-29
• Study First Posted: 2016-08-03
• Last Update Posted: 2016-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	no dosage of iPTH	no dosage of iPTH
Experimental group	iPTH	iPTH at 6 hours after surgery

Primary Outcome Measures

Name	Time	Method
Sensibility and specificity of iPTH and serum calcium measurement	1 month	Sensitivity and specificity of serum measurement using the Receiver-operator characteristics (ROC) curve