ThyroidNCT03079193
Post Thyroidectomy Endoscopic Laryngeal Examination :Is it Mandatory?
An observational study of Thyroid, run by Khamis Mushayt General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Thyroid
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Feb 2014
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older 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
Who may be able to join
- all post thyroidectomy patients
Who cannot join
- -
About this study
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.
Read the 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.
- Conditions
- Thyroid
- Keywords
- post thyroidectomy, laryngeoscopic examination
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
endoscopic laryngeal examination post thyroidectomy
usefulness of endoscopic laryngeal examination post thyroidectomy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study startJan 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Khamis Mushayt General Hospital
- Sponsor type
- Other government
- Collaborators
- Mansoura University
- Responsible party
- Principal investigator, wagih ghnnam, Khamis Mushayt General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079193
- Sponsor's protocol ID
- khamisMGH WA1
- Status last verified
- Mar 2017
- First submitted
- 13 Mar 2014
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Thyroidectomy Endoscopic Laryngeal Examination :Is it Mandatory?
- ClinicalTrials.gov ID
- NCT03079193
- Acronym / sponsor ID
- khamisMGH WA1
- Conditions
- Thyroid
- Keywords
- post thyroidectomy, laryngeoscopic examination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Khamis Mushayt General HospitalOther government
- Collaborators
- Mansoura University
- Study start
- Jan 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (1 listed)
- all post thyroidectomy patients
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
endoscopic laryngeal examination post thyroidectomy
Time frame: 3 years
usefulness of endoscopic laryngeal examination post thyroidectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid, run by Khamis Mushayt General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endoscopic laryngeal examination post thyroidectomy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.