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Early Prediction of Hypocalcaemia Following Thyroid Surgery

Primary Purpose

Hypocalcemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iPTH
no dosage of iPTH
Sponsored by
University of Cagliari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypocalcemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Experimental group

    Control group

    Arm Description

    iPTH at 6 hours after surgery

    no dosage of iPTH

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 6, 2016
    Last Updated
    July 29, 2016
    Sponsor
    University of Cagliari
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02853721
    Brief Title
    Early Prediction of Hypocalcaemia Following Thyroid Surgery
    Official Title
    Early Prediction of Hypocalcaemia Following Thyroid Surgery: A Prospective Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Cagliari

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypocalcemia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    iPTH at 6 hours after surgery
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    no dosage of iPTH
    Intervention Type
    Other
    Intervention Name(s)
    iPTH
    Intervention Description
    iPTH assay six hours after surgery
    Intervention Type
    Other
    Intervention Name(s)
    no dosage of iPTH
    Intervention Description
    Ca and P on postoperative day 1 and 2
    Primary Outcome Measure Information:
    Title
    Sensibility and specificity of iPTH and serum calcium measurement
    Description
    Sensitivity and specificity of serum measurement using the Receiver-operator characteristics (ROC) curve
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Early Prediction of Hypocalcaemia Following Thyroid Surgery

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