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Completed

NCT Number: NCT02853721

Early Prediction of Hypocalcaemia Following Thyroid Surgery

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.

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Key information

Conditions

Hypocalcemia Calcium Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iPTH

Other

iPTH assay six hours after surgery

no dosage of iPTH

Other

Ca and P on postoperative day 1 and 2

Primary outcomes

  1. Sensibility and specificity of iPTH and serum calcium measurement

    Time frame: 1 month

    Sensitivity and specificity of serum measurement using the Receiver-operator characteristics (ROC) curve

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 3, 2016
Registry last updated
Aug 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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