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

Study Overview
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Brief Summary
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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.

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

Conditions
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Thyroid Nodule

Intervention / Treatment
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* Procedure: Mini-flap
* Procedure: Conventional flap


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional flap<br>BABA robotic-thyroidectomy that using conventional flap | Procedure: Conventional flap<br>* Conventional flap BABA robotic-thyroidectomy creates flaps up to the thyroid cartilage<br>|
| Active Comparator: Mini-flap<br>BABA robotic-thyroidectomy that using Mini-flap | Procedure: Mini-flap<br>* Mini-flap BABA robotic-thyroidectomy creates flaps up to the cricoid cartilage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mini-flap, Bilateral axillo-breast approach, Da vinci, Robot-assisted thyroid surgery