Complications of Endocrine Surgery: Data From the United... | NCT01539499

Studies
Complications of Endocrine Surgery: Data From the United HealthSystem Consortium

NCT01539499

Sponsor

University of Arkansas

Status

Completed

Last Update Posted

Aug 31, 2017Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Thyroid Disease
Parathyroid Disease
Endocrine Gland

Interventions

Not provided

Countries

United States

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

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

Jan 2010

Primary Completion Date

Aug 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Feb 21, 2012

First Submission Date that Met QC Criteria

Feb 24, 2012

First Posted Date

Feb 27, 2012Estimated

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

Aug 30, 2017

Last Update Posted Date

Aug 31, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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

1,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Non endocrine surgery patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brendan Stack, MD	University of Arkansas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas for Medical Sciences		Little Rock	Arkansas	72205	United States

Condition Browse Module

MeSH Terms

ID	Term
D013959	Thyroid Diseases
D010279	Parathyroid Diseases

Ancestor Terms

ID	Term
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided