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

NCT05216718 | Unknown

• 1 other identifier: 2021-10-014-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Nodule

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Incidence of vocal cord palsy

  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

  before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery

Study Arms (2)

Conventional flap

EXPERIMENTAL

BABA robotic-thyroidectomy that using conventional flap

Procedure: Conventional flap

Mini-flap

ACTIVE COMPARATOR

BABA robotic-thyroidectomy that using Mini-flap

Procedure: Mini-flap

Interventions

Mini-flap PROCEDURE

Mini-flap BABA robotic-thyroidectomy creates flaps up to the cricoid cartilage

Mini-flap

Conventional flap PROCEDURE

Conventional flap BABA robotic-thyroidectomy creates flaps up to the thyroid cartilage

Conventional flap

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Inje University: lead

Study Sites (1)

Dong sik Bae

Busan, South Korea

Location

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 31, 2022
• Study Start: January 24, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 1, 2023
• Last Updated: January 31, 2022

Record last verified: 2022-01

Locations

KR (1)