NCT01539486

Brief Summary

The intent for this study is to do a retrospective chart review of all patients who have undergone minimally invasive parathyroidectomy for primary hyperthyroidism. All data collected will be recorded under assigned identification numbers that will have no association with medical record or hospital numbers. Identifying characteristics will include age and sex. Anonymity will be upheld. The patient/family will not be contacted directly. All information will be obtained from the medical chart. Demographics, location, preoperative PTH levels and intraoperative Ex-Vivo gamma counts, co-morbid conditions, and the outcome based on the hospital notes will be obtained from patients' charts and will be transferred to a secure database. It is our hypothesis that there is a linear relationship between immediate preoperative parathyroid hormone (PTH) levels and Ex-Vivo gamma counts and the aim of this study is to better describe this relationship.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 15, 2023

Status Verified

January 1, 2023

Enrollment Period

12.9 years

First QC Date

February 21, 2012

Last Update Submit

September 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Retrospective Chart Review

    The information presented in this report will provide a surgical tool for otolaryngologists to improve the efficiency and efficacy in patients with hyperparathyroid disease.

    Retrospective Chart Review

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

An estimated 200 patient charts will be reviewed.

You may qualify if:

  • Patients must be between the ages of 18 and 90 years old who have documented primary hyperparathyroidism and have undergone minimally invasive parathyroidectomy.

You may not qualify if:

  • Patients who have not had both intraoperative parathyroid hormone (PTH) levels and Gamma counts during their parathyroidectomy
  • Patients who have parathyroidectomies for reasons other than primary hyperparathyroidism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Parathyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Deanne King, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2012

First Posted

February 27, 2012

Study Start

January 1, 2010

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

September 15, 2023

Record last verified: 2023-01

Locations