ThyroidectomyNCT03922282
BABA Robotic Thyroidectomy Without Gas is Safe Enough as That Use a Gas
A study testing Gasless BABA and Classic BABA in people with Thyroidectomy and Thyroid Diseases, run by Inje University at 1 site in South Korea.
Trial summary
In this study, a randomized controlled study was conducted between two groups of 14 classic recipients of Carbon dioxide insufflation during BABA robotic-thyroidectomy and 14 recipients of Gasless method during BABA robotic-thyroidectomy. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Thyroidectomy, Thyroid Diseases
- What is being tested?
- Gasless BABA and Classic BABA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jan 2018to 8 Oct 2018
- Phase
- Interventional
- 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 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject who will have thyroid surgery
Who cannot join
- Subject who underwent thyroid surgery
- Subject who underwent any radiotherapy on neck
- Subject who need to neck dissection
- Subject under 18 years or over 70 years
- Bad general condition
- High American Society of Anesthesiologists(ASA) score (over 3)
- Breast feeder or pregnancy
- Subject who disagree to do this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, and Controlled Study of the Safety and Efficacy in Gasless BABA(Bilateral Axillo-breast Approach) Robotic Thyroidectomy
In this study, a randomized controlled study was conducted between two groups of 14 classic recipients of Carbon dioxide insufflation during BABA robotic-thyroidectomy and 14 recipients of Gasless method during BABA robotic-thyroidectomy. This is a study to see if there is any difference in hemodynamic and metabolic changes and pain .
- Conditions
- Thyroidectomy, Thyroid Diseases
- Being tested
- Gasless BABA, Classic BABA
- Keywords
- Gasless, Bilateral axillo-breast approach, Da Vinci, Robot-assisted thyroid surgery
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gasless BABAProcedure or surgery
BABA robotic-thyroidectomy that is using elevation of flap instead of using carbon dioxide.
Classic BABAProcedure or surgery
BABA robotic-thyroidectomy that is using carbon dioxide.
| Study group | Role | What they receive |
|---|---|---|
| Gasless BABA | Experimental | BABA robotic-thyroidectomy that do not using carbon dioxide but using elevation of flap. Receives: Procedure: Gasless BABA |
| Classic BABA | Active comparator | BABA robotic-thyroidectomy using carbon dioxide. Receives: Procedure: Classic BABA |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
heart rate in beats per minute
Measured: Change from baseline heart rate at the end of surgery
mean arterial pressure
mean arterial pressure in mmHg
Measured: Change from baseline mean arterial pressure at the end of surgery
cardiac index
cardiac index in L/min/m^2, divide the cardiac output by the person's body surface area, measured by the Vigileo monitor, normal range is 2.5 to 4.5L/min/m2
Measured: Change from baseline cardiac index at the end of surgery
cardiac output
cardiac output in L/minute, calculated by multiplying the stroke volume by the heart rate, measured by the Vigileo monitor
Measured: Change from baseline cardiac output at the end of surgery
pH
pH
Measured: Change from baseline pH at the end of surgery
PaCO2
PaCO2 in mmHg
Measured: Change from baseline PaCO2 at the end of surgery
VAS(visual analog score)
Visual Analog Score for pain, range from 0 to 10, Higher the values represents more pains
Measured: change from baseline VAS up to 3days after surgery
BHC(bottom hit count)
bottom hit count from intravenous patient controlled analgesia for pain
Measured: change from baseline BHC up to 3days after surgery
number of analgesics
number of analgesics(additional ketorolac uses)
Measured: change from baseline number of analgesics up to 3days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start3 Jan 2018
- Primary completion31 Aug 2018
- Study completion8 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongsik Bae, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922282
- Sponsor's protocol ID
- 2017-08-009-004
- Status last verified
- Apr 2019
- First submitted
- 20 Feb 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, and Controlled Study of the Safety and Efficacy in Gasless BABA(Bilateral Axillo-breast Approach) Robotic Thyroidectomy
- ClinicalTrials.gov ID
- NCT03922282
- Acronym / sponsor ID
- 2017-08-009-004
- Conditions
- Thyroidectomy, Thyroid Diseases
- Keywords
- Gasless, Bilateral axillo-breast approach, Da Vinci, Robot-assisted thyroid surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 19 Apr 2019 (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.
In this study, a randomized controlled study was conducted between two groups of 14 classic recipients of Carbon dioxide insufflation during BABA robotic-thyroidectomy and 14 recipients of Gasless method during BABA robotic-thyroidectomy. This is a study to see if there is any difference in hemodynamic and metabolic changes and pain .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gasless BABA | Experimental | Procedure: Gasless BABABABA robotic-thyroidectomy that do not using carbon dioxide but using elevation of flap. |
| Classic BABA | Active comparator | Procedure: Classic BABABABA robotic-thyroidectomy using carbon dioxide. |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject who will have thyroid surgery
Key exclusion criteria (8 listed)
- Subject who underwent thyroid surgery
- Subject who underwent any radiotherapy on neck
- Subject who need to neck dissection
- Subject under 18 years or over 70 years
- Bad general condition
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 |
|---|---|---|
| Gasless BABABABA robotic-thyroidectomy that is using elevation of flap instead of using carbon dioxide. | Procedure or surgery | Gasless BABA |
| Classic BABABABA robotic-thyroidectomy that is using carbon dioxide. | Procedure or surgery | Classic BABA |
Primary outcome
heart rate
Time frame: Change from baseline heart rate at the end of surgery
heart rate in beats per minute
mean arterial pressure
Time frame: Change from baseline mean arterial pressure at the end of surgery
mean arterial pressure in mmHg
cardiac index
Time frame: Change from baseline cardiac index at the end of surgery
cardiac index in L/min/m^2, divide the cardiac output by the person's body surface area, measured by the Vigileo monitor, normal range is 2.5 to 4.5L/min/m2
cardiac output
Time frame: Change from baseline cardiac output at the end of surgery
cardiac output in L/minute, calculated by multiplying the stroke volume by the heart rate, measured by the Vigileo monitor
pH
Time frame: Change from baseline pH at the end of surgery
pH
PaCO2
Time frame: Change from baseline PaCO2 at the end of surgery
PaCO2 in mmHg
VAS(visual analog score)
Time frame: change from baseline VAS up to 3days after surgery
Visual Analog Score for pain, range from 0 to 10, Higher the values represents more pains
BHC(bottom hit count)
Time frame: change from baseline BHC up to 3days after surgery
bottom hit count from intravenous patient controlled analgesia for pain
number of analgesics
Time frame: change from baseline number of analgesics up to 3days after surgery
number of analgesics(additional ketorolac uses)
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 19 Apr 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gasless BABA and Classic BABA in people with Thyroidectomy and Thyroid Diseases, run by Inje University at 1 site in South Korea.
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 8 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 19 Apr 2019. 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 South Korea. 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?
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?
heart rate (time frame: Change from baseline heart rate at the end of surgery). The study lists 9 primary outcomes in all. 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 19 Apr 2019; AzTrials last refreshed its copy on 29 Oct 2026.