Thyroid Carcinoma Clinical Trial
Official title:
Arathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function
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 |
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | General Surgery Unit, ICOT Hospital | Latina |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Italy,
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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