Mini-flap BABA (Bilateral Axillo-breast Approach) Robotic Thyroidectomy is Safe
Primary Purpose
Thyroid Nodule
Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mini-flap
Conventional flap
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Nodule focused on measuring Mini-flap, Bilateral axillo-breast approach, Da vinci, Robot-assisted thyroid surgery
Eligibility Criteria
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
Sites / Locations
- Dong sik Bae
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Conventional flap
Mini-flap
Arm Description
BABA robotic-thyroidectomy that using conventional flap
BABA robotic-thyroidectomy that using Mini-flap
Outcomes
Primary Outcome Measures
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
change from baseline in pain, as measured by the number of analgesics uses
number of analgesics(additional ketorolac uses)
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
Secondary Outcome Measures
Incidence of vocal cord palsy
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
check PTH (parathyroid hormone) level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05216718
Brief Title
Mini-flap BABA (Bilateral Axillo-breast Approach) Robotic Thyroidectomy is Safe
Official Title
Prospective Randomized Controlled Study on Mini-flap Bilateral Axillo-breast Approach Robotic Thyroidectomy : Effect on Postoperative Pain and Sensation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 24, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule
Keywords
Mini-flap, Bilateral axillo-breast approach, Da vinci, Robot-assisted thyroid surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional flap
Arm Type
Experimental
Arm Description
BABA robotic-thyroidectomy that using conventional flap
Arm Title
Mini-flap
Arm Type
Active Comparator
Arm Description
BABA robotic-thyroidectomy that using Mini-flap
Intervention Type
Procedure
Intervention Name(s)
Mini-flap
Intervention Description
Mini-flap BABA robotic-thyroidectomy creates flaps up to the cricoid cartilage
Intervention Type
Procedure
Intervention Name(s)
Conventional flap
Intervention Description
Conventional flap BABA robotic-thyroidectomy creates flaps up to the thyroid cartilage
Primary Outcome Measure Information:
Title
Change from baseline in pain, as measured by the Visual Analog Score(VAS)
Description
Visual Analog Score for pain, range from 0 to 10, Higher the values represents more pains
Time Frame
2, 24, 48, 72 hours after surgery
Title
change from baseline in pain, as measured by the number of analgesics uses
Description
number of analgesics(additional ketorolac uses)
Time Frame
2, 24, 48, 72 hours after surgery
Title
change from baseline in Sensory change, as measured by the monofilaments
Description
Six monofilaments were used to measure the pressure threshold of the 2 chest zones and 2 neck zones
Time Frame
1 day before surgery, 1, 3 months after surgery
Secondary Outcome Measure Information:
Title
Incidence of vocal cord palsy
Description
Check vocal cord palsy that means injury of the recurrent laryngeal nerve with a direct laryngoscope
Time Frame
before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery
Title
change from baseline in Hypoparathyroidism, as measured by parathyroid hormone level
Description
check PTH (parathyroid hormone) level
Time Frame
before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Dong sik Bae
City
Busan
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Mini-flap BABA (Bilateral Axillo-breast Approach) Robotic Thyroidectomy is Safe
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