Prospective Randomized Controlled Study on Mini-flap Bilateral Axillo-breast Approach Robotic Thyroidectomy : Effect on Postoperative Pain and Sensation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- change from baseline in pain, as measured by the number of analgesics uses
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Conventional flap
BABA robotic-thyroidectomy that using conventional flap
干预措施: Conventional flap (Procedure)
Mini-flap
BABA robotic-thyroidectomy that using Mini-flap
干预措施: Mini-flap (Procedure)
结局指标
主要结局
change from baseline in pain, as measured by the number of analgesics uses
时间窗: 2, 24, 48, 72 hours after surgery
number of analgesics(additional ketorolac uses)
Change from baseline in pain, as measured by the Visual Analog Score(VAS)
时间窗: 2, 24, 48, 72 hours after surgery
Visual Analog Score for pain, range from 0 to 10, Higher the values represents more pains
change from baseline in Sensory change, as measured by the monofilaments
时间窗: 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
Postoperative pain measured using a visual analog scale
时间窗: 2, 24, 48, and 72 hours after surgery
Postoperative pain was assessed using a visual analog scale ranging from 0 to 10, with higher scores indicating greater pain.
Rescue analgesic use
时间窗: 2, 24, 48, and 72 hours after surgery
Number of additional doses of ketorolac administered for postoperative pain.
Change from baseline in sensory function as measured by Semmes-Weinstein monofilaments
时间窗: 1 day before surgery and 1, 6 and 12 months after surgery
Sensory function was assessed using six Semmes-Weinstein monofilaments to measure pressure detection thresholds in four predefined anatomical regions: the superior anterior neck, inferior anterior neck, right anterior chest, and left anterior chest.
次要结局
- 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)
研究者
Dongsik Bae
Associate Professor
Inje University