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

Inje University

Status: Unknown

Conditions: Thyroid Nodule

Treatments: Procedure: Conventional flap; Procedure: Mini-flap

Study type: Interventional

Funder types: Other

Identifiers

NCT05216718

2021-10-014-001

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 19 to 69 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Conventional flap

Experimental group

Description:

BABA robotic-thyroidectomy that using conventional flap

Treatment:

Procedure: Conventional flap

Mini-flap

Active Comparator group

Description:

BABA robotic-thyroidectomy that using Mini-flap

Treatment:

Procedure: Mini-flap