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NCT04372225 Clinical Trial

Predicting Risk Factors of Postoperative Hypocalcemia After Total Thyroidectomy

Hypoparathyroidism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04372225
Other study ID # ArixMU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 25, 2020
Est. completion date April 25, 2020

Study information
Verified date April 2020
Source Aix Marseille Université
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 477
Est. completion date April 25, 2020
Est. primary completion date April 25, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• analysis of hypocalcemia
analysis of postoperative calcium and PTH levels

Locations
Country Name City State
France Conception Hospital Marseille

Sponsors (1)
Lead Sponsor Collaborator
Aix Marseille Université

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary calcium and PTH thresholds 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
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