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
• 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

• Goiter
• Graves Disease
• Graves Diseases
• Multinodular Goiter
• Thyroid Carcinoma
• Thyroid Diseases
• Thyroid Goiter
• Thyroid Neoplasms

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