Parathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function
Sponsor
University of Roma La Sapienza (Other)
Overall Status
Completed
CT.gov ID
NCT02194920
Collaborator
(none)
20
1
1
19.6
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
20 participants
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
Study Start Date
:
Oct 1, 2014
Actual Primary Completion Date
:
Oct 1, 2014
Actual Study Completion Date
:
Nov 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Parathyroid reimplantation
|
Procedure: Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue
|
Outcome Measures
Primary Outcome Measures
- Assessment of parathyroid tissue graft function by selective (left or right) parathormone measurement by vein blood sample [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
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients affected by benign thyroid disease undergoing thyroidectomy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | General Surgery Unit, ICOT Hospital | Latina | Italy | 04100 |
Sponsors and Collaborators
- University of Roma La Sapienza
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Giuseppe Cavallaro,
Giuseppe Cavallaro, MD PhD,
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT02194920
Other Study ID Numbers:
- 06072011
First Posted:
Jul 18, 2014
Last Update Posted:
Nov 5, 2014
Last Verified:
Nov 1, 2014
Additional relevant MeSH terms: