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

Not Applicable

• Conditions: Thyroid Nodule
• Interventions: Procedure: Conventional flap; Procedure: Mini-flap

• Registration Number: NCT05216718
• Lead Sponsor: Inje University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-30
• Status Verified: 2022-01
• Study Start: 2022-01-24
• Study First Submitted QC: 2022-01-27
• Last Update Submitted: 2022-01-27
• Study First Posted: 2022-01-31
• Last Update Posted: 2022-01-31
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional flap	Conventional flap	BABA robotic-thyroidectomy that using conventional flap
Mini-flap	Mini-flap	BABA robotic-thyroidectomy that using Mini-flap

Primary Outcome Measures

Name	Time	Method
change from baseline in pain, as measured by the number of analgesics uses	2, 24, 48, 72 hours after surgery	number of analgesics(additional ketorolac uses)
Change from baseline in pain, as measured by the Visual Analog Score(VAS)	2, 24, 48, 72 hours after surgery	Visual Analog Score for pain, range from 0 to 10, Higher the values represents more pains
change from baseline in Sensory change, as measured by the monofilaments	1 day before surgery, 1, 3 months after surgery	Six monofilaments were used to measure the pressure threshold of the 2 chest zones and 2 neck zones

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dong sik Bae; 🇰🇷 Busan, Korea, Republic of