A Prospective Comparison of Robotic and Endoscopic SMG Resection Via Retroauricular Approach
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- length of incision
研究概览
简要总结
Traditional transcervical incision of the upper neck is a safe and effective approach for resection of the submandibular gland (SMG). However, external scar at the highly visible area may be a burden for the patients and sometimes may lead to disfiguring hypertrophic scar or keloid. Recently, the investigators reported our surgical technique of 'endoscope-assisted' and 'robot-assisted' SMG resection, which was feasible and showed excellent cosmetic outcomes since the scar was hidden by the auricle and hair. In our previous feasibility study of robot-assisted SMG resection, the investigators proposed that robot-assisted technique may overcome the limitations of endoscopic instruments with rigid and straight nature without articulation and surgical view of two-dimension. In addition, the ergonomically designed operating system was more convenient for the surgeon considering the frequent collision of the endoscopic instruments and reversed hand-eye coordination in endoscope-assisted surgery. However, clinical trial comparing the surgical outcomes of the two techniques has not been reported in the literature.
In this study, the investigators made a prospective comparative study of robot-assisted versus endoscope-assisted SMG resection to determine whether robot-assisted technique has benefits regarding early surgical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as pleomorphic adenoma or chronic sialadenitis from preoperative ultrasound-guided fine needle aspiration biopsy (FNAB)
排除标准
- •Past history of neck surgery or radiation
- •Possible malignancy expected from FNAB or image study
- •Gland with severe adhesion to surrounding tissue on preoperative physical examination
结局指标
主要结局
length of incision
时间窗: expected average opeartion time : 60~90 minutes
length of incision is measure by a surgical ruler after before skin incision
次要结局
- amount and duration of drainage(on the day of discharge from hospital (expected average period : postoperative 3 days))
- hospital stay(on the day of discharge from hospital (expected average period : postoperative 3 days))
- complications(on the day of discharge from hospital (expected average period : postoperative 3 days))
