Phoniatric Evaluation of Total ThyroidectomyNCT01865006
Phoniatric Evaluation and Comparison of Patients Who Underwent Sutureless Thyroidectomy With Vessel Closure Devices and Conventional Total Thyroidectomy With Suture
An observational study of Phoniatric Evaluation of Total Thyroidectomy, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare effect of sutureless thyroidectomy with vessel closure devices and conventional thyroidectomy with suturing on voice quality with phoniatric evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phoniatric Evaluation of Total Thyroidectomy
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2013to Apr 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent to total thyroidectomy.
Who may be able to join
None listed.
Who cannot join
- Pre-operative voice problems
- Pre-operative vocal cord paralysis
- Singers and teachers
- Pre-operative known advanced stage malignity
- Previously operated for thyroid diseases.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Cerrahpasa Medical Faculty Department of General Surgery
Istanbul, 34098
Server Sezgin ULUDAĞ, MD, +905334933676, sszgn.uludag@gmail.com
Server Sezgin ULUDAG, MD
About this study
The purpose of this study is to compare effect of sutureless thyroidectomy with vessel closure devices and conventional thyroidectomy with suturing on voice quality with phoniatric evaluation.
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 |
|---|---|---|
| Ligasure LF1212 | Not described | |
| Ultracision | Not described | |
| Conventional | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice quality change in relation with operative technique
Voice quality change between postoperative 1st week and 2nd month in relation with operative technique (either sutureless (with Ligasure or Ultracision) or conventional technique) via Voice handicap index, videolaryngostroboscope, CSL MDVP advanced software, and Glottography.
Measured: Postoperative 1st week and 2nd month
Secondary outcomes (1)
Voice quality change in relation with histopathology.
Voice quality change between postoperative 1st week and 2nd month in relation with histopathology via Voice handicap index, videolaryngostroboscope, CSL MDVP advanced software, and Glottography.
Measured: 1st week and 2nd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phoniatric Evaluation of Total ThyroidectomyStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Server Sezgin Uludag, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865006
- Sponsor's protocol ID
- IUCTF-2013-01
- Status last verified
- May 2013
- First submitted
- 21 May 2013
- Last updated
- 30 May 2013
- Results posted
- No
Publications
Uludag SS, Teksoz S, Arikan AE, Tarhan O, Yener HM, Ozcan M, Liddy W, Randolph GW. Effect of energy-based devices on voice quality after total thyroidectomy. Eur Arch Otorhinolaryngol. 2017 May;274(5):2295-2302. doi: 10.1007/s00405-016-4444-0. Epub 2017 Feb 25.
PubMed 28238161
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phoniatric Evaluation and Comparison of Patients Who Underwent Sutureless Thyroidectomy With Vessel Closure Devices and Conventional Total Thyroidectomy With Suture
- ClinicalTrials.gov ID
- NCT01865006
- Acronym / sponsor ID
- IUCTF-2013-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Apr 2014 (estimated)
- First posted
- 30 May 2013 (estimated)
- 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.
The purpose of this study is to compare effect of sutureless thyroidectomy with vessel closure devices and conventional thyroidectomy with suturing on voice quality with phoniatric evaluation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ligasure LF1212 | – | – |
| Ultracision | – | – |
| Conventional | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent to total thyroidectomy.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Pre-operative voice problems
- Pre-operative vocal cord paralysis
- Singers and teachers
- Pre-operative known advanced stage malignity
- Previously operated for thyroid diseases.
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
Voice quality change in relation with operative technique
Time frame: Postoperative 1st week and 2nd month
Voice quality change between postoperative 1st week and 2nd month in relation with operative technique (either sutureless (with Ligasure or Ultracision) or conventional technique) via Voice handicap index, videolaryngostroboscope, CSL MDVP advanced software, and Glottography.
1 secondary outcome
Voice quality change in relation with histopathology.
Time frame: 1st week and 2nd month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
- Derived from this study: PubMed 28238161Uludag SS, Teksoz S, Arikan AE, Tarhan O, Yener HM, Ozcan M, Liddy W, Randolph GW. Effect of energy-based devices on voice quality after total thyroidectomy. Eur Arch Otorhinolaryngol. 2017 May;274(5):2295-2302. doi: 10.1007/s00405-016-4444-0. Epub 2017 Feb 25.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phoniatric Evaluation of Total Thyroidectomy, run by Istanbul University at 1 site in Turkey (Türkiye).
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 0 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Server Sezgin ULUDAG, MD (+905334933676, sszgn.uludag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice quality change in relation with operative technique (time frame: Postoperative 1st week and 2nd month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01865006, which also lists 1 linked publication.
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 30 May 2013.