Post Thyroidectomy Endoscopic Laryngeal Examination :Is i... | NCT03079193

Studies
Post Thyroidectomy Endoscopic Laryngeal Examination :Is it Mandatory?

NCT03079193

Sponsor

Khamis Mushayt General Hospital

Status

Completed

Last Update Posted

Mar 14, 2017Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Thyroid

Interventions

Not provided

Countries

Not provided

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

Mar 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 2011

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Mar 13, 2014

First Submission Date that Met QC Criteria

Mar 8, 2017

First Posted Date

Mar 14, 2017Actual

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

Mar 8, 2017

Last Update Posted Date

Mar 14, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

wagih ghnnam, associate professor of general surgery, Khamis Mushayt General HospitalPrincipal Investigator

Lead Sponsor

Khamis Mushayt General HospitalOTHER_GOV

Collaborators

Name	Class
Mansoura University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Post thyroidectomy laryngeal nerve injuries are frequently encountered specially in total and near total thyroidectomy some unilateral injuries are not clinically evident and asymptomatic.

The aim of this study is to compare mandatory versus selective post-thyroidectomy endoscopic examination of larynx to detect laryngeal nerve injuries.

Detailed Description

100 patients were randomly divided into two groups, group I for whom mandatory post thyroidectomy endoscopic laryngoscopic examination and the other group of only symptomatic patients selected for direct laryngoscopic examination.

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

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
videoscopic laryngeal examination		50 patients post thyroidectomy will do mandatory post thyroidectomy videoscopic examination of the larynx
No vedioscopic larygeoscopic examination		50 patients post thyroidectomy will be followed up and will not do vedeoscopic videoscopic laryngeal examination routinely they will do it if indicated

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
endoscopic laryngeal examination post thyroidectomy	usefulness of endoscopic laryngeal examination post thyroidectomy	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all post thyroidectomy patients

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

100 patients post thyroidectomy will be randomly divided into two groups group I for whom mandatory vedioscopic laryngeal examination is done while the other group II patients for whom no routine vedioscopic laryngeal examination done only if symptoms developed

Sampling Method

Probability Sample

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
D013959	Thyroid Diseases

Ancestor Terms

ID	Term
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided