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

Prospective Randomized Controlled Study on Mini-flap Bilateral Axillo-breast Approach Robotic Thyroidectomy : Effect on Postoperative Pain and Sensation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05216718

Enrollment

Registered

2022-01-31

Start date

2022-01-24

Completion date

2026-12-01

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Nodule

Keywords

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

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 69 Years

Healthy volunteers

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain measured using a visual analog scale	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	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	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.

Secondary

Measure	Time frame	Description
Incidence of vocal cord palsy	before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery	Check vocal cord palsy that means injury of the recurrent laryngeal nerve with a direct laryngoscope
change from baseline in Hypoparathyroidism, as measured by parathyroid hormone level	before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery	check PTH (parathyroid hormone) level

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026