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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional flap | Experimental | BABA robotic-thyroidectomy that using conventional flap |
|
| Mini-flap | Active Comparator | BABA robotic-thyroidectomy that using Mini-flap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mini-flap | Procedure | Mini-flap BABA robotic-thyroidectomy creates flaps up to the cricoid cartilage |
|
| 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 |
| 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 |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong sik Bae | Busan | South Korea |
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| ID | Term |
|---|---|
| D016606 | Thyroid Nodule |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Conventional flap | Procedure | Conventional flap BABA robotic-thyroidectomy creates flaps up to the thyroid cartilage |
|
check PTH (parathyroid hormone) level |
| before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery |
| D006258 |
| Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |