Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total Thyroidectomy

Completed

• Conditions: Hypoparathyroidism
• Interventions: Biological: immediate post operative bioassay of Parathyroid Hormone

• Registration Number: NCT02924532
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The main objective of this study is to establish an optimal threshold Early parathormon (PTH) assay in order to exclude hypoparathyroidism , that is to say to obtain a negative predictive value of hypoparathyroidism highest possible.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2013-12
• Status Verified: 2016-09
• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-10-04
• Last Update Submitted: 2016-10-04
• Study First Posted: 2016-10-05
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients consecutively operated on between February 1, 2012 and December 1, 2013
• Total thyroidectomy +/- lymphadenectomy
• Respect of clinicobiological protocol presented above
• The ( the ) patient ( e) was informed ( e) on the implementation of the study 's objectives, constraints and patient rights
• The ( the ) patient ( e) is under ( e) at least 18 years

Exclusion Criteria

• The ( the ) patient ( e) is under guardianship, curatorship or under guard saves justice
• It is not possible to give to ( the ) patient ( e) informed information
• History of cervical radiotherapy
• Previous history of dysfunction of the parathyroid glands
• Previous history of surgery of the parathyroid glands
• A history of kidney failure or hepatocellular
• History of osteomalacia or Paget's disease
• unhealed cancer antecedent
• History of sarcoidosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with total thiroidectomy	immediate post operative bioassay of Parathyroid Hormone	-

Primary Outcome Measures

Name	Time	Method
the presence/absence of hypoparathyroidism	day 1	hypoparathyroidism is defined as: corrected serum calcium Day 1 \<1.90 and / or symptoms of hypocalcemia (cramps, tingling of the extremities and peri-oral) to Day 1 authenticated by a VAS score\> 3.