NCT02853721

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
Last Updated

August 3, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

May 6, 2016

Last Update Submit

July 29, 2016

Conditions

Hypocalcemia

Outcome Measures

Primary Outcomes (1)

  • Sensibility and specificity of iPTH and serum calcium measurement

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

    1 month

Study Arms (2)

Experimental group

EXPERIMENTAL

iPTH at 6 hours after surgery

Other: iPTH

Control group

OTHER

no dosage of iPTH

Other: no dosage of iPTH

Interventions

iPTHOTHER

iPTH assay six hours after surgery

Experimental group
no dosage of iPTHOTHER

Ca and P on postoperative day 1 and 2

Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Be submitted to total thyroidectomy during the study period
  • Have signed the informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypocalcemia

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 6, 2016

First Posted

August 3, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

April 1, 2015

Last Updated

August 3, 2016

Record last verified: 2016-07