NCT03079193

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

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, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2014

Completed
3 years until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

3.1 years

First QC Date

March 13, 2014

Last Update Submit

March 8, 2017

Conditions

Thyroid

Keywords

post thyroidectomylaryngeoscopic examination

Outcome Measures

Primary Outcomes (1)

  • endoscopic laryngeal examination post thyroidectomy

    usefulness of endoscopic laryngeal examination post thyroidectomy

    3 years

Study Arms (2)

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

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • all post thyroidectomy patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of general surgery

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 14, 2017

Study Start

January 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 14, 2017

Record last verified: 2017-03