Thyroid NoduleNCT05216718
Mini-flap BABA (Bilateral Axillo-breast Approach) Robotic Thyroidectomy is Safe
A study testing Mini-flap and Conventional flap in people with Thyroid Nodule, 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 40 recipients of conventional flap during BABA robotic-thyroidectomy and 40 recipients of Mini-flap method during BABA robotic-thyroidectomy. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Mini-flap and Conventional flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jan 2022to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- subjects who will have thyroid surgery
- subjects who has no evidence of lymph node metastasis on palpation and imaging (cN0)
- subjects who has thyroid nodule under 4cm (<cT2)
- subjects who has no distant metastasis (M0)
Who cannot join
- subjects who has clinical evidence of lymph node metastasis (cN1a or cN1b)
- subjects who has both thyroid nodule
- subjects who underwent any radiotherapy on neck
- subjects who has primary hyperparathyroidism
- subjects who underwent head and neck surgery
- subjects who disagree to do this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Study on Mini-flap Bilateral Axillo-breast Approach Robotic Thyroidectomy : Effect on Postoperative Pain and Sensation
In this study, a randomized controlled study was conducted between two groups of 40 recipients of conventional flap during BABA robotic-thyroidectomy and 40 recipients of Mini-flap method during BABA robotic-thyroidectomy. In this study, we tried to determine whether the use of Mini-flap can reduce sensory loss and pain after BABA robotic-thyroidectomy.
- Conditions
- Thyroid Nodule
- Being tested
- Mini-flap, Conventional flap
- Keywords
- Mini-flap, Bilateral axillo-breast approach, Da vinci, Robot-assisted thyroid surgery
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-flapProcedure or surgery
Mini-flap BABA robotic-thyroidectomy creates flaps up to the cricoid cartilage
Conventional flapProcedure or surgery
Conventional flap BABA robotic-thyroidectomy creates flaps up to the thyroid cartilage
| Study group | Role | What they receive |
|---|---|---|
| Conventional flap | Experimental | BABA robotic-thyroidectomy that using conventional flap Receives: Procedure: Conventional flap |
| Mini-flap | Active comparator | BABA robotic-thyroidectomy that using Mini-flap Receives: Procedure: Mini-flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain measured using a visual analog scale
Postoperative pain was assessed using a visual analog scale ranging from 0 to 10, with higher scores indicating greater pain.
Measured: 2, 24, 48, and 72 hours after surgery
Rescue analgesic use
Number of additional doses of ketorolac administered for postoperative pain.
Measured: 2, 24, 48, and 72 hours after surgery
Change from baseline in sensory function as measured by Semmes-Weinstein monofilaments
Sensory function was assessed using six Semmes-Weinstein monofilaments to measure pressure detection thresholds in four predefined anatomical regions: the superior anterior neck, inferior anterior neck, right anterior chest, and left anterior chest.
Measured: 1 day before surgery and 1, 6 and 12 months after surgery
Secondary outcomes (2)
Incidence of vocal cord palsy
Check vocal cord palsy that means injury of the recurrent laryngeal nerve with a direct laryngoscope
Measured: before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery
change from baseline in Hypoparathyroidism, as measured by parathyroid hormone level
check PTH (parathyroid hormone) level
Measured: before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start24 Jan 2022
- Primary completion30 Jun 2024
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies 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
- 82 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
- NCT05216718
- Sponsor's protocol ID
- 2021-10-014-001
- Status last verified
- Sep 2026
- First submitted
- 30 Dec 2021
- Last updated
- 11 Sep 2026
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study on Mini-flap Bilateral Axillo-breast Approach Robotic Thyroidectomy : Effect on Postoperative Pain and Sensation
- ClinicalTrials.gov ID
- NCT05216718
- Acronym / sponsor ID
- 2021-10-014-001
- Conditions
- Thyroid Nodule
- Keywords
- Mini-flap, Bilateral axillo-breast approach, Da vinci, Robot-assisted thyroid surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 31 Jan 2022 (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 40 recipients of conventional flap during BABA robotic-thyroidectomy and 40 recipients of Mini-flap method during BABA robotic-thyroidectomy. In this study, we tried to determine whether the use of Mini-flap can reduce sensory loss and pain after BABA robotic-thyroidectomy.
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 |
|---|---|---|
| Conventional flap | Experimental | Procedure: Conventional flapBABA robotic-thyroidectomy that using conventional flap |
| Mini-flap | Active comparator | Procedure: Mini-flapBABA robotic-thyroidectomy that using Mini-flap |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- subjects who will have thyroid surgery
- subjects who has no evidence of lymph node metastasis on palpation and imaging (cN0)
- subjects who has thyroid nodule under 4cm (<cT2)
- subjects who has no distant metastasis (M0)
Key exclusion criteria (6 listed)
- subjects who has clinical evidence of lymph node metastasis (cN1a or cN1b)
- subjects who has both thyroid nodule
- subjects who underwent any radiotherapy on neck
- subjects who has primary hyperparathyroidism
- subjects who underwent head and neck 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 |
|---|---|---|
| Mini-flapMini-flap BABA robotic-thyroidectomy creates flaps up to the cricoid cartilage | Procedure or surgery | Mini-flap |
| Conventional flapConventional flap BABA robotic-thyroidectomy creates flaps up to the thyroid cartilage | Procedure or surgery | Conventional flap |
Primary outcome
Postoperative pain measured using a visual analog scale
Time frame: 2, 24, 48, and 72 hours after surgery
Postoperative pain was assessed using a visual analog scale ranging from 0 to 10, with higher scores indicating greater pain.
Rescue analgesic use
Time frame: 2, 24, 48, and 72 hours after surgery
Number of additional doses of ketorolac administered for postoperative pain.
Change from baseline in sensory function as measured by Semmes-Weinstein monofilaments
Time frame: 1 day before surgery and 1, 6 and 12 months after surgery
Sensory function was assessed using six Semmes-Weinstein monofilaments to measure pressure detection thresholds in four predefined anatomical regions: the superior anterior neck, inferior anterior neck, right anterior chest, and left anterior chest.
2 secondary outcomes
Incidence of vocal cord palsy
Time frame: before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery
change from baseline in Hypoparathyroidism, as measured by parathyroid hormone level
Time frame: before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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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 Mini-flap and Conventional flap in people with Thyroid Nodule, 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Postoperative pain measured using a visual analog scale (time frame: 2, 24, 48, and 72 hours after surgery). The study lists 3 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 11 Sep 2026.