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NCT02924532 Clinical Trial

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

Hypoparathyroidism Clinical Trial

Official title:
Diagnostic Value of Immediate Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total Thyroidectomy: A Retrospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02924532
Other study ID # LOCAL/2014/BL-01
Secondary ID
Status Completed
Phase N/A
First received September 13, 2016
Last updated October 4, 2016
Start date February 2012

Study information
Verified date September 2016
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Biological:
• immediate post operative bioassay of Parathyroid Hormone

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome
Type Measure Description Time frame Safety issue
Primary the presence/absence of hypoparathyroidism 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. day 1 No
See also
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Active, not recruiting NCT05965167 - Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo Phase 1/Phase 2
Recruiting NCT02986607 - Corticosteroid Rhythms in Hypoparathyroid Patients Early Phase 1