Active, not recruitingNCT05216718Updated Sep 11, 2026

Mini-flap BABA (Bilateral Axillo-breast Approach) Robotic Thyroidectomy is Safe

An interventional study of Mini-flap and Conventional flap in Thyroid Nodule, sponsored by Inje University. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Inje University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 82
Allocation: Randomized
Ages: 19 Years to 69 Years
Sex: All

Study 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. In this study, we tried to determine whether the use of Mini-flap can reduce sensory loss and pain after BABA robotic-thyroidectomy.

Conditions studied

Thyroid Nodule

Browse trials for

Thyroid Nodule 199

Keywords

Mini-flap
Bilateral axillo-breast approach
Da vinci
Robot-assisted thyroid surgery

Who can participate

Ages eligible: 19 Years to 69 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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)

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 82 participants (actual)

Study arms

Experimental
Conventional flap
BABA robotic-thyroidectomy that using conventional flap
Procedure: Conventional flap
Active comparator
Mini-flap
BABA robotic-thyroidectomy that using Mini-flap
Procedure: Mini-flap

Interventions

ProcedureMini-flap
Mini-flap BABA robotic-thyroidectomy creates flaps up to the cricoid cartilage
ProcedureConventional flap
Conventional flap BABA robotic-thyroidectomy creates flaps up to the thyroid cartilage

What researchers measure

Primary outcomes

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.
Time frame: 2, 24, 48, and 72 hours after surgery
Rescue analgesic use
Number of additional doses of ketorolac administered for postoperative pain.
Time frame: 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.
Time frame: 1 day before surgery and 1, 6 and 12 months after surgery

Secondary outcomes

Incidence of vocal cord palsy
Check vocal cord palsy that means injury of the recurrent laryngeal nerve with a direct laryngoscope
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
check PTH (parathyroid hormone) level
Time frame: before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery

Study locations

1 site

Dong sik Bae
Busan, South Korea

Registry details

Key details

Study ID: NCT05216718
Lead sponsor: Inje University
Responsible party: Dongsik Bae (Associate Professor, Inje University) — Principal investigator
First posted: Jan 31, 2022
Start date: Jan 24, 2022
Primary completion: Jun 30, 2024
Completion: Dec 1, 2026 (estimated)
Last update: Sep 11, 2026

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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