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

• Sponsor: Inje University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05216718
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22.2
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Nodule	Procedure: Mini-flap; Procedure: Conventional flap	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prospective Randomized Controlled Study on Mini-flap Bilateral Axillo-breast Approach Robotic Thyroidectomy : Effect on Postoperative Pain and Sensation
• Anticipated Study Start Date: Jan 24, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Conventional flap BABA robotic-thyroidectomy that using conventional flap	Procedure: Conventional flap; Conventional flap BABA robotic-thyroidectomy creates flaps up to the thyroid cartilage
Active Comparator: Mini-flap BABA robotic-thyroidectomy that using Mini-flap	Procedure: Mini-flap; Mini-flap BABA robotic-thyroidectomy creates flaps up to the cricoid cartilage

Outcome Measures

Primary Outcome Measures

1. 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

2. 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)

3. 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

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dong sik Bae	Busan		Korea, Republic of

Sponsors and Collaborators

• Inje University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dongsik Bae, Associate Professor, Inje University
• ClinicalTrials.gov Identifier: NCT05216718
• Other Study ID Numbers: 2021-10-014-001
• First Posted: Jan 31, 2022
• Last Update Posted: Jan 31, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dongsik Bae, Associate Professor, Inje University: Mini-flap; Bilateral axillo-breast approach; Da vinci; Robot-assisted thyroid surgery
• Additional relevant MeSH terms: Thyroid Nodule

Study Results

No Results Posted as of Jan 31, 2022