Quality of LifeNCT03048539
Comparison of Quality of Life Between Patients Underwent Transoral Endoscopic Thyroid Surgery and Conventional Surgery
An observational study of Quality of Life and Transoral Endoscopic Thyroidectomy, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine the quality of life of transoral endoscopic thyroidectomy compare with open thyroidectomy, Furthermore, postoperative complication will be assessed, also. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Transoral Endoscopic Thyroidectomy, Conventional Thyroidectomy
- What is being tested?
- Transoral endoscopic thyroidectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteThailand
- Study dates
- 6 Feb 2017to 31 Dec 2019
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patient who underwent thyroid lobectomy
Who may be able to join
- Patient who underwent thyroid lobectomy for benign thyroid nodule less or equal 5 cm
Who cannot join
- previous neck surgery
- suspected thyroid carcinoma
- patient who failure endoscopic thyroidectomy and change to conventional surgery
Trial locations and contacts
1 site in 1 country.
Pornthep Kasemsiri, MD contact
Srongpaun Trakulkajornsak, MD contact
Thailand1 site, 1 recruiting
- Recruiting
Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002
Pornthep Kasemsiri, M.D., Pkasemsiri99@gmail.com
About this study
The purpose of this study is to determine the quality of life of transoral endoscopic thyroidectomy compare with open thyroidectomy, Furthermore, postoperative complication will be assessed, also.
Read the detailed description
Regarding type of surgery, doctor will just advice about risk and benefit of any type of surgery. And then patient will select by himself. Patients are not assigned to endoscopic or conventional group.
This study start to enrolled patients after surgery. And the quality of life will be observed at 2, 6 and 12 weeks, respectively.
- Being tested
- Transoral endoscopic thyroidectomy
- Keywords
- Endoscopic surgery, Thyroidectomy, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral endoscopic thyroidectomyProcedure or surgery
This procedure will remove thyroid lobe through oral vestibule. Aim to avoid scar at anterior neck.
| Study group | Role | What they receive |
|---|---|---|
| Transoral endoscopic thyroidectomy | Patient who fit with the eligible criteria and choose endoscopic thyroidectomy by himself. Receives: Procedure: Transoral endoscopic thyroidectomy | |
| Conventional thyroidectomy | Patient who fit with the eligible criteria and choose conventional thyroidectomy by himself. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life after surgery
Quality of life will assessed by Short form health survey 36 and specific questionnaire for thyroidectomy. These questionnaires will assess at 2,6 and 12 weeks after surgery. The quality of life results (6 and 12 weeks) will be observed that change from 2 weeks after surgery. Furthermore, investigators will compare score of Short form health survey 36 and specific quality of life questionnaire for thyroidectomy between endoscopic and open technique at 2,6,12 week after surgery, also.
Measured: 2,6,12 weeks
Secondary outcomes (1)
Postoperative complication
The complications will assess at 2,6, and 12 week after surgery.
Measured: 2,6, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start6 Feb 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornthep Kasemsiri, Khon Kaen University
- Investigators
- Pornthep Kasemsiri, MD, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048539
- Sponsor's protocol ID
- HE591505
- Status last verified
- Mar 2017
- First submitted
- 2 Feb 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Anuwong A. Transoral Endoscopic Thyroidectomy Vestibular Approach: A Series of the First 60 Human Cases. World J Surg. 2016 Mar;40(3):491-7. doi: 10.1007/s00268-015-3320-1.
PubMed 26546193Kasemsiri P, Trakulkajornsak S, Bamroong P, Mahawerawat K, Piromchai P, Ratanaanekchai T. Comparison of quality of life between patients undergoing trans-oral endoscopic thyroid surgery and conventional open surgery. BMC Surg. 2020 Jan 29;20(1):18. doi: 10.1186/s12893-020-0685-3.
PubMed 31996201
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quality of Life Between Patients Underwent Transoral Endoscopic Thyroid Surgery and Conventional Surgery
- ClinicalTrials.gov ID
- NCT03048539
- Acronym / sponsor ID
- HE591505
- Keywords
- Endoscopic surgery, Thyroidectomy, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 9 Feb 2017 (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 determine the quality of life of transoral endoscopic thyroidectomy compare with open thyroidectomy, Furthermore, postoperative complication will be assessed, also.
Detailed description
Regarding type of surgery, doctor will just advice about risk and benefit of any type of surgery. And then patient will select by himself. Patients are not assigned to endoscopic or conventional group.
This study start to enrolled patients after surgery. And the quality of life will be observed at 2, 6 and 12 weeks, respectively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transoral endoscopic thyroidectomy | – | Procedure: Transoral endoscopic thyroidectomyPatient who fit with the eligible criteria and choose endoscopic thyroidectomy by himself. |
| Conventional thyroidectomy | – | –Patient who fit with the eligible criteria and choose conventional thyroidectomy by himself. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patient who underwent thyroid lobectomy
Key inclusion criteria (1 listed)
- Patient who underwent thyroid lobectomy for benign thyroid nodule less or equal 5 cm
Key exclusion criteria (3 listed)
- previous neck surgery
- suspected thyroid carcinoma
- patient who failure endoscopic thyroidectomy and change to conventional surgery
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 |
|---|---|---|
| Transoral endoscopic thyroidectomyThis procedure will remove thyroid lobe through oral vestibule. Aim to avoid scar at anterior neck. | Procedure or surgery | Transoral endoscopic thyroidectomy |
Primary outcome
Change in quality of life after surgery
Time frame: 2,6,12 weeks
Quality of life will assessed by Short form health survey 36 and specific questionnaire for thyroidectomy. These questionnaires will assess at 2,6 and 12 weeks after surgery. The quality of life results (6 and 12 weeks) will be observed that change from 2 weeks after surgery. Furthermore, investigators will compare score of Short form health survey 36 and specific quality of life questionnaire for thyroidectomy between endoscopic and open technique at 2,6,12 week after surgery, also.
1 secondary outcome
Postoperative complication
Time frame: 2,6, and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Results publication: PubMed 26546193Anuwong A. Transoral Endoscopic Thyroidectomy Vestibular Approach: A Series of the First 60 Human Cases. World J Surg. 2016 Mar;40(3):491-7. doi: 10.1007/s00268-015-3320-1.
- Derived from this study: PubMed 31996201Kasemsiri P, Trakulkajornsak S, Bamroong P, Mahawerawat K, Piromchai P, Ratanaanekchai T. Comparison of quality of life between patients undergoing trans-oral endoscopic thyroid surgery and conventional open surgery. BMC Surg. 2020 Jan 29;20(1):18. doi: 10.1186/s12893-020-0685-3.
- 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.
Pornthep Kasemsiri, MD contact
Srongpaun Trakulkajornsak, MD contact
Pornthep Kasemsiri, MD principal investigator
Khon Kaen University
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 Quality of Life and Transoral Endoscopic Thyroidectomy, run by Khon Kaen University at 1 site in Thailand.
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 3 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 7 Mar 2017. 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 Thailand. 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 Pornthep Kasemsiri, MD (Pkasemsiri99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life after surgery (time frame: 2,6,12 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 NCT03048539, which also lists 2 linked publications.
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 7 Mar 2017.