NCT01539499

Brief Summary

The goal of this study is to help better determine the complication rates for endocrine surgery across the nation for both benign and malignant disease. It is our hypothesis that the complication rates are low overall and that malignant disease results in a higher complication rate than benign disease. This study will do a database review from all University HealthSystem Consortium (UHC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ 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

Click on a node to explore related trials.

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
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

7.6 years

First QC Date

February 21, 2012

Last Update Submit

August 30, 2017

Conditions

Thyroid DiseaseParathyroid DiseaseEndocrine Gland

Outcome Measures

Primary Outcomes (1)

  • Complication Rates for Endocrine Surgery

    The information presented in this report will provide a surgical tool for otolaryngologists to safely inform patients on the risks of endocrine surgery.

    baseline

Eligibility Criteria

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

The study will be conducted through a United HealthSystem Consortium query of endocrine surgery done as a primary procedure for specific diagnosis.

You may qualify if:

  • All patients between the ages of 18 and 90 years who have a diagnosis of benign multinodular goiter and/or malignant thyroid disease and have undergone a total thyroidectomy as a primary procedure.
  • Parathyroid patients will also be studied.

You may not qualify if:

  • Non endocrine surgery patients

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

Thyroid DiseasesParathyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Brendan Stack, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
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

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 31, 2017

Record last verified: 2017-08

Locations

US(1)