Early Prediction of Hypocalcemia After Thyroidectomy Usin... | NCT03717116

Studies
Early Prediction of Hypocalcemia After Thyroidectomy Using Postoperative Second Hour Parathormone

NCT03717116

Sponsor

Istanbul University

Status

Unknown status

Last Update Posted

Oct 24, 2018Actual

Enrollment

110Estimated

Phase

Not provided

Conditions

Hypocalcemia, Postoperative Parathormone

Interventions

parathormone level

Countries

Turkey (Türkiye)

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

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Oct 31, 2018Estimated

Completion Date

Dec 1, 2018Estimated

First Submitted Date

Oct 22, 2018

First Submission Date that Met QC Criteria

Oct 22, 2018

First Posted Date

Oct 24, 2018Actual

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

Oct 22, 2018

Last Update Posted Date

Oct 24, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Hypocalcemia is the most frequent complication in thyroid surgeries. Diagnosing this complication earlier will reduce longer hospital stay and will lead to an earlier intervention. The purpose of the study is to evaluate postoperative second hour parathyroid hormone measurement as a predictor for early stage hypocalcemia.

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

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control-normocalcemia group			Diagnostic Test: parathormone level
hypocalcemia group			Diagnostic Test: parathormone level

Interventions

Name	Type	Description	Arm Group Labels	Other Names
parathormone level	Diagnostic Test	From the patients, blood will be taken preoperatively and postoperatively.	control-normocalcemia group hypocalcemia group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative parathormone level		postoperative 2. hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with multinodular goiter, Graves, fine needle aspiartion biopsy with Bethesda 3-4 undergoing total thyroidectomy

Exclusion Criteria:

pregnant women
patients with thyroid cancer or previous neck dissection

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

all patients with multinodular goiter, Graves, fine needle aspiartion biopsy with Bethesda 3-4 undergoing total thyroidectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
selen soylu	Contact	+905375653811		selen_soylu@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul University	Recruiting	Istanbul		34158	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006996	Hypocalcemia

Ancestor Terms

ID	Term
D002128	Calcium Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D014883	Water-Electrolyte Imbalance

Browse Leaves

Not provided

Browse Branches

Not provided