Predicting Risk Factors of Postoperative Hypocalcemia After Total Thyroidectomy

April 30, 2020 updated by: Paladino Nunzia Cinzia, Aix Marseille Université

Predicting Risk Factors of Postoperative Hypocalcemia After Total Thyroidectomy: is Safe Discharge Without Supplementation Possible?

With increasing economic pressures to shorten the length of hospital stay, there has been much recent interest in studying risk factors for the development of postoperative hypocalcemia.

The aim of this study was to investigate in patients undergoing total thyroidectomy whether serum calcium and/or PTH levels can predict hypoparathyroidism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our study consists of analyzing the calcium (mmol/l) and PTH (pmol/l) levels on the first postoperative day. Postoperative treatment with calcium and vitamin D and the length of hospital stay is also taken into consideration.

We also analyze post-operative complications.

Study Type

Observational

Enrollment (Actual)

477

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13005
        • Conception hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Analysis of calcium and PTH levels in postoperative day 1

Description

Inclusion Criteria:

• Total thyroidectomy

Exclusion Criteria:

  • concomitant parathyroidectomy for primary hyperparathyroidism
  • lobectomy only
  • completion thyroidectomy
  • central and lateral neck dissection
  • patients with calcium and/or vitamin D supplementation prior surgery
  • patients with known and significant osteoporosis and renal failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
477 patients
the biological tests of 477 patients undergoing total thyroidectomy were analyzed
Other: analysis of hypocalcemia
analysis of postoperative calcium and PTH levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
calcium and PTH thresholds
Time Frame: one years

For all 477 patients postoperative calcium and PTH levels and treatment with calcium and vitamin D will be analyzed.

Objective is to identify the calcium and PTH thresholds at which the patient after total thyroidectomy can be discharged without risk of hypocalcemia.
one years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aix Marseille Université

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2020

Primary Completion (Actual)

April 25, 2020

Study Completion (Actual)

April 25, 2020

Study Registration Dates

First Submitted

April 25, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 1, 2020

Study Record Updates

Last Update Posted (Actual)

May 1, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ArixMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

the data are confidential

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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