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NCT02194920 Clinical Trial

Parathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function

Thyroid Carcinoma Clinical Trial

Official title:
Arathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02194920
Other study ID # 06072011
Secondary ID
Status Completed
Phase N/A
First received July 3, 2014
Last updated November 4, 2014
Start date October 2014
Est. completion date November 2014

Study information
Verified date November 2014
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority Italy: Istituto Superiore di Sanità
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate safety and effectiveness of normal parathyroid tissue reimplantation in forearm subcutaneous tissue in case of accidental removal of parathyroid gland during thyroid surgery.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date November 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients affected by benign thyroid disease undergoing thyroidectomy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue

Locations
Country Name City State
Italy General Surgery Unit, ICOT Hospital Latina

Sponsors (1)
Lead Sponsor Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of parathyroid tissue graft function by selective (left or right) parathormone measurement by vein blood sample The primary outcome will be the assessment of reimplanted parathyroid function, evaluated by intact Parathormone (iPTH) measurement by separate blood samples (left and right arm) at 7 days, 1 month and 3 months after surgery. Ratio of 1.5 between the iPTH levels in the arm receiving graft and the opposite arm will be predictive of graft functionality up to 3 months No
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