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

Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05216718
• Other study ID #: 2021-10-014-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 24, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2022
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Nodule

Intervention

Procedure:
• Mini-flap
Mini-flap BABA robotic-thyroidectomy creates flaps up to the cricoid cartilage
• Conventional flap
Conventional flap BABA robotic-thyroidectomy creates flaps up to the thyroid cartilage

Locations

Country	Name	City	State
Korea, Republic of	Dong sik Bae	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain, as measured by the Visual Analog Score(VAS)	Visual Analog Score for pain, range from 0 to 10, Higher the values represents more pains	2, 24, 48, 72 hours after surgery
Primary	change from baseline in pain, as measured by the number of analgesics uses	number of analgesics(additional ketorolac uses)	2, 24, 48, 72 hours after surgery
Primary	change from baseline in Sensory change, as measured by the monofilaments	Six monofilaments were used to measure the pressure threshold of the 2 chest zones and 2 neck zones	1 day before surgery, 1, 3 months after surgery
Secondary	Incidence of vocal cord palsy	Check vocal cord palsy that means injury of the recurrent laryngeal nerve with a direct laryngoscope	before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery
Secondary	change from baseline in Hypoparathyroidism, as measured by parathyroid hormone level	check PTH (parathyroid hormone) level	before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery