Early Prediction of Hypocalcaemia Following Thyroid Surgery

Sponsor

University of Cagliari (Other)

Overall Status

Completed

CT.gov ID

NCT02853721

Collaborator

(none)

150

Enrollment

Arms

14.9

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypocalcemia	Other: iPTH Other: no dosage of iPTH	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Cagliari

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alessandra Saba, Doctor, University of Cagliari

ClinicalTrials.gov Identifier:

NCT02853721

Other Study ID Numbers:

PG/2014/9514

First Posted:

Aug 3, 2016

Last Update Posted:

Aug 3, 2016

Last Verified:

Jul 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Hypocalcemia

Study Results

No Results Posted as of Aug 3, 2016