Parathyroid Reimplantation in Forearm Subcutaneous Tissue... | NCT02194920

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

NCT02194920

Sponsor

University of Roma La Sapienza

Status

Completed

Last Update Posted

Nov 5, 2014Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Thyroid Goiter
Thyroid Carcinoma
Multinodular Goiter
Graves Diseases

Interventions

Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Oct 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Jul 3, 2014

First Submission Date that Met QC Criteria

Jul 17, 2014

First Posted Date

Jul 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2014

Last Update Posted Date

Nov 5, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giuseppe Cavallaro, Giuseppe Cavallaro, MD PhD, University of Roma La SapienzaPrincipal Investigator

Lead Sponsor

University of Roma La SapienzaOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parathyroid reimplantation			Procedure: Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue	Procedure		Parathyroid reimplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients affected by benign thyroid disease undergoing thyroidectomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients receiving thyroid surgery with accidental removal or devascularization of normal parathyroid gland

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Surgery Unit, ICOT Hospital		Latina		04100	Italy

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D013959	Thyroid Diseases
D004700	Endocrine System Diseases
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

ID	Term
D013507	Endocrine Surgical Procedures
D013514	Surgical Procedures, Operative

ID	Term
D006042	Goiter
D013964	Thyroid Neoplasms