Early Prediction of Hypocalcaemia Following Thyroid Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Hypocalcemia
• Intervention / Treatment: Other: iPTH; Other: no dosage of iPTH

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; iPTH at 6 hours after surgery	Other: iPTH; iPTH assay six hours after surgery
Other: Control group; no dosage of iPTH	Other: no dosage of iPTH; Ca and P on postoperative day 1 and 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensibility and specificity of iPTH and serum calcium measurement	Sensitivity and specificity of serum measurement using the Receiver-operator characteristics (ROC) curve	1 month

Collaborators and Investigators

• Sponsor: University of Cagliari

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (Estimate): August 3, 2016

Study Record Updates

• Last Update Posted (Estimate): August 3, 2016
• Last Update Submitted That Met QC Criteria: July 29, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Water-Electrolyte Imbalance; Hypocalcemia
• Other Study ID Numbers: PG/2014/9514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided