ThyroidectomyNCT02683551
Comparison of QoL for Sutureless Thyroidectomy
An observational study of Thyroidectomy and Quality of Life, run by Istanbul University.
Trial summary
Patients underwent thyroidectomy filled an computer or paper based QoL questionnaire before and after operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroidectomy, Quality of Life
- What is being tested?
- Sutureless Thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 193 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2016
- 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 has planned to undergo to sutureless thyroidectomy for benign conditions.
Who may be able to join
- Sutureless thyroidectomy for benign conditions
Who cannot join
- Known neck malignity,
- History of neck operation
- Ligation use during surgery
- Refusal of patient
- Non-capable patient
- Non-euthyroid patient
Show all 9Show fewer
- Pregnancy
- Having rheumatic diseases
- Having connective tissue diseases
About this study
Official title: Comparison of Effects of Energy Based Devices on Quality of Life After Sutureless Thyroidectomy?
Patients underwent thyroidectomy filled an computer or paper based QoL questionnaire before and after operation.
Read the detailed description
Patients who have consent to undergo to total thyroidectomy with sutureless technique (regardless of attending to study or not) for benign thyroid diseases in the institution are asked to participate to this study. Patients are informed that participating to this study will not alter their treatment method. Patients were operated either with Ligasure SmallJaw or Harmonic Focus according to result of label picked from bag. Same surgical team performed all operations and they did not know if the patient was participated in study or not.
Patients willing to participate in this study are being questioned for their quality of life (QoL) with a patient-reported outcome (PRO) questionnaire before surgery and 4 weeks after surgery. For assessment of quality of life Thy-PRO-39 questionnaire is being used. Responses of patients to QoL questionnaire is being recorded to a secure online database. After data completion answers of patients will be exported as anonymous to principal investigator for analysis. Effect of two energy based devices (EBD) on QOL will be compared.
- Conditions
- Thyroidectomy, Quality of Life
- Being tested
- Sutureless Thyroidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sutureless ThyroidectomyProcedure or surgery
Thyroidectomy performed with energy based devices and no use of ligation. Used device is not altered for this study. Non of the personnel in the operating room including surgical team knows if the patient was enrolled or not in this study.
| Study group | Role | What they receive |
|---|---|---|
| Ligasure | Patients underwent to Sutureless Thyroidectomy with Ligasure SmallJaw Receives: Procedure: Sutureless Thyroidectomy | |
| Harmonic | Patients underwent to Sutureless Thyroidectomy with Harmonic FOCUS Receives: Procedure: Sutureless Thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall alterations in quality of life according to Thy-PRO-39 questionnaire
Measured: 4 weeks
Secondary outcomes (7)
Alterations in social life according to Thy-PRO-39 questionnaire
Measured: 4 weeks
Alterations in daily life according to Thy-PRO-39 questionnaire
Measured: 4 weeks
Alterations in Tiredness according to Thy-PRO-39 questionnaire
Measured: 4 weeks
Alterations in cognitive complaints according to Thy-PRO-39 questionnaire
Measured: 4 weeks
Alterations in anxiety according to Thy-PRO-39 questionnaire
Measured: 4 weeks
Alterations in depressivity according to Thy-PRO-39 questionnaire
Measured: 4 weeks
Alterations in emotional susceptibility according to Thy-PRO-39 questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionJun 2016
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 ThyroidectomyStudies 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
- Cross-sectional
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akif Enes ARIKAN, Istanbul University
- Investigators
- Ates OZYEGIN, Prof, MD, Study director, Istanbul University, Cerrahpasa Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683551
- Sponsor's protocol ID
- IUCTF-EndSx-2015-01
- Other IDs
- 83045809/604.01/02
- Status last verified
- Apr 2024
- First submitted
- 24 Oct 2015
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Watt T, Bjorner JB, Groenvold M, Cramon P, Winther KH, Hegedus L, Bonnema SJ, Rasmussen AK, Ware JE Jr, Feldt-Rasmussen U. Development of a Short Version of the Thyroid-Related Patient-Reported Outcome ThyPRO. Thyroid. 2015 Oct;25(10):1069-79. doi: 10.1089/thy.2015.0209. Epub 2015 Aug 26.
PubMed 26214034
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Energy Based Devices on Quality of Life After Sutureless Thyroidectomy?
- ClinicalTrials.gov ID
- NCT02683551
- Acronym / sponsor ID
- IUCTF-EndSx-2015-01
- Conditions
- Thyroidectomy, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Feb 2016 (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.
Patients underwent thyroidectomy filled an computer or paper based QoL questionnaire before and after operation.
Detailed description
Patients who have consent to undergo to total thyroidectomy with sutureless technique (regardless of attending to study or not) for benign thyroid diseases in the institution are asked to participate to this study. Patients are informed that participating to this study will not alter their treatment method. Patients were operated either with Ligasure SmallJaw or Harmonic Focus according to result of label picked from bag. Same surgical team performed all operations and they did not know if the patient was participated in study or not.
Patients willing to participate in this study are being questioned for their quality of life (QoL) with a patient-reported outcome (PRO) questionnaire before surgery and 4 weeks after surgery. For assessment of quality of life Thy-PRO-39 questionnaire is being used. Responses of patients to QoL questionnaire is being recorded to a secure online database. After data completion answers of patients will be exported as anonymous to principal investigator for analysis. Effect of two energy based devices (EBD) on QOL will be compared.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ligasure | – | Procedure: Sutureless ThyroidectomyPatients underwent to Sutureless Thyroidectomy with Ligasure SmallJaw |
| Harmonic | – | Procedure: Sutureless ThyroidectomyPatients underwent to Sutureless Thyroidectomy with Harmonic FOCUS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who has planned to undergo to sutureless thyroidectomy for benign conditions.
Key inclusion criteria (1 listed)
- Sutureless thyroidectomy for benign conditions
Key exclusion criteria (9 listed)
- Known neck malignity,
- History of neck operation
- Ligation use during surgery
- Refusal of patient
- Non-capable patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sutureless ThyroidectomyThyroidectomy performed with energy based devices and no use of ligation. Used device is not altered for this study. Non of the personnel in the operating room including surgical team knows if the patient was enrolled or not in this study. | Procedure or surgery | Harmonic, Ligasure |
Primary outcome
Overall alterations in quality of life according to Thy-PRO-39 questionnaire
Time frame: 4 weeks
7 secondary outcomes
Alterations in social life according to Thy-PRO-39 questionnaire
Time frame: 4 weeks
Alterations in daily life according to Thy-PRO-39 questionnaire
Time frame: 4 weeks
Alterations in Tiredness according to Thy-PRO-39 questionnaire
Time frame: 4 weeks
Alterations in cognitive complaints according to Thy-PRO-39 questionnaire
Time frame: 4 weeks
Alterations in anxiety according to Thy-PRO-39 questionnaire
Time frame: 4 weeks
Alterations in depressivity according to Thy-PRO-39 questionnaire
Time frame: 4 weeks
Alterations in emotional susceptibility according to Thy-PRO-39 questionnaire
Time frame: 4 weeks
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 9 Apr 2024.
- Background: PubMed 26214034Watt T, Bjorner JB, Groenvold M, Cramon P, Winther KH, Hegedus L, Bonnema SJ, Rasmussen AK, Ware JE Jr, Feldt-Rasmussen U. Development of a Short Version of the Thyroid-Related Patient-Reported Outcome ThyPRO. Thyroid. 2015 Oct;25(10):1069-79. doi: 10.1089/thy.2015.0209. Epub 2015 Aug 26.
- Data collection and information release systemLink provided by the sponsor.
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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.
Ates OZYEGIN, Prof, MD study director
Istanbul University, Cerrahpasa Medical Faculty
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroidectomy and Quality of Life, run by Istanbul University.
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 9 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 9 Apr 2024. 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?
Overall alterations in quality of life according to Thy-PRO-39 questionnaire (time frame: 4 weeks). 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 NCT02683551, 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 9 Apr 2024; AzTrials last refreshed its copy on 1 Nov 2026.