A Pilot Study Assessing Robotic Surgery in the Seated or Supine Position for Benign and Malignant Lesions of the Head and Neck Using the da Vinci Robotic Surgical Systems and Modified Transoral Instrumentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- TORS surgery completion in the seated position
研究概览
简要总结
This study is designed to investigate if transoral surgery with the patient in the seated position utilizing the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) will enable better visualization and expedited removal of benign and malignant tumors of the throat.
详细描述
The da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) being evaluated in this pilot study consists of 3 basic components: a surgeon's console, articulated mechanical arms and sterilizable instruments. The console includes a computer, video monitor and instrument controls, and is located in the operating room adjacent to the operating room table. The console is connected via computer to the mechanical arms holding the endoscope (surgical TV camera) and sterile surgical tools (e.g., forceps, scissors, electrocautery, etc.). These arms are located immediately adjacent to the patient on the operating room table. The surgeon sits at the console and controls the position and movement of the arms and surgical tools. The design of these tools is based upon well-established, commonly used surgical instruments. The da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) is a "manual image-guided surgery" system that is computer enhanced rather than "computer guided robotic surgery" in which the surgeon programs the computer to do the surgery and the robot does the surgery (also known as a "milling" device). Use of the da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in the aforementioned configuration in fact facilitates an exact translation of the surgeon's hand and finger movements at the console to precise and tremor-free movements of the arms and instruments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient must present with indications for diagnostic or therapeutic surgery for benign or malignant diseases of the head and neck.
- •Written informed consent.
- •Pre-Operative
排除标准
- •Unexplained fever and/or untreated, active infection.
- •Patient pregnancy.
- •Previous head and neck surgery precluding robotic procedures.
- •The presence of medical conditions contraindicating general anesthesia or standard surgical approaches.
- •Intra-Operative Exclusion Criteria:
- •It is recognized that sometimes patients cannot be excluded from study participation until prepped in the surgical suite such that their anatomy is exposed and available for medical analysis. The following situations represent instances whereby which patients would be excluded from this study based upon anatomical findings not evident in the pre-operative setting:
- •Inability to adequately visualize anatomy or place robotic instrumentation to perform the diagnostic or therapeutic surgical approach in the seated position.
- •In this circumstance, the procedure would be completed by standard robotic transoral surgery or an alternative approach may be chosen.
研究组 & 干预措施
Trans Oral Robotic Surgery (TORS)
Patient's are having TORS surgery in a seated position
干预措施: Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device (Device)
结局指标
主要结局
TORS surgery completion in the seated position
时间窗: Measures assessed at time of intervention (during surgery)
Recording how many participants' surgery was completed in the seated position
次要结局
- Length of participants' surgical time(Measures assessed at time of intervention (during surgery))
- Estimated amount of blood loss during participants' surgery(Measures assessed at time of intervention (during surgery))
研究者
Kathryn (Katie) M. Van Abel
Principal Investigator
Mayo Clinic