Early Prediction of Hypocalcaemia Following Thyroid Surgery

Hypocalcemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02853721
• Other study ID #: PG/2014/9514
• Status: Completed
• Phase: N/A
• First received: May 6, 2016
• Last updated: July 29, 2016
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: July 2016
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypocalcemia

Intervention

Other:
• iPTH
iPTH assay six hours after surgery
• no dosage of iPTH
Ca and P on postoperative day 1 and 2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Cagliari

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensibility and specificity of iPTH and serum calcium measurement	Sensitivity and specificity of serum measurement using the Receiver-operator characteristics (ROC) curve	1 month	No