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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02194920
First Posted: July 18, 2014
Last Update Posted: November 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Giuseppe Cavallaro, University of Roma La Sapienza
  Purpose
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.

Condition Intervention
Thyroid Goiter Thyroid Carcinoma Multinodular Goiter Graves Diseases Procedure: Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Arathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function

Resource links provided by NLM:


Further study details as provided by Giuseppe Cavallaro, University of Roma La Sapienza:

Primary Outcome Measures:
  • Assessment of parathyroid tissue graft function by selective (left or right) parathormone measurement by vein blood sample [ Time Frame: up to 3 months ]
    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


Enrollment: 20
Study Start Date: October 2014
Study Completion Date: November 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Parathyroid reimplantation Procedure: Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients receiving thyroid surgery with accidental removal or devascularization of normal parathyroid gland
Criteria

Inclusion Criteria:

  • Patients affected by benign thyroid disease undergoing thyroidectomy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194920


Locations
Italy
General Surgery Unit, ICOT Hospital
Latina, Italy, 04100
Sponsors and Collaborators
University of Roma La Sapienza
  More Information

Responsible Party: Giuseppe Cavallaro, Giuseppe Cavallaro, MD PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02194920     History of Changes
Other Study ID Numbers: 06072011
First Submitted: July 3, 2014
First Posted: July 18, 2014
Last Update Posted: November 5, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Graves Disease
Goiter
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Exophthalmos
Orbital Diseases
Eye Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases