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A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery

2016年3月15日 更新者:Richard V. Smith, MD、Montefiore Medical Center
  1. Patients included will have benign or malignant lesions with treatment plan for endoscopic resection or resection by other minimally invasive techniques.
  2. They will be offered a robotic approach to their surgery using the DaVinci robotic surgical system (intuitive Surgical, Inc.).
  3. The objectives are to evaluate our ability to adequately visualize the surgical field and perform the intended surgery without a higher complication rate.
  4. Secondary objective include evaluation of blood loss, length of hospital stay, complications while using the DaVinci robot system, and quality of life in subjects and historical controls undergoing similar surgery without the robot or radiation therapy.
  5. To evaluate recurrence, survival and other outcome data in robotic surgery patients compared with similar historical control groups (matched with respect to stage, prior and subsequent treatment, age, tumor HPV positivity) of patients who have undergone standard surgery without the robot or radiation/chemoradiation treatment as an alternative to surgery.

5. Endpoints will be compared to historical controls.

研究概览

详细说明

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).22 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.

研究类型

介入性

注册 (实际的)

71

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • Bronx、New York、美国、10467
        • Montefiore Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • At least 18 years f age
  • Indications for diagnostic or therapeutic approaches for benign or malignant disease of the head and neck
  • Written informed consent

Exclusion Criteria:

  • Unexplained fever and/or untreated, active infection
  • Pregnancy
  • Previous head and neck surgery precluding transoral/endoscopic/robotic procedures
  • Presence of medical conditions contraindicating general anesthesia or transoral surgical approaches

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:1
robot assisted endoscopic head and neck surgery
Planned endoscopic surgery of the head and neck performed with the DaVinci Robotic Surgical System

研究衡量的是什么?

主要结果指标

结果测量
大体时间
ability to adequately visualize the operative field and complete planned surgery
大体时间:1 day
1 day

次要结果测量

结果测量
大体时间
complication rate compared to standard endoscopic and minimally invasive procedures
大体时间:1 month
1 month
blood loss compared to historical controls of endoscopic and minimally invasive procedures
大体时间:1 day
1 day
quality of life at early (1-3 months) and late (one year)
大体时间:1 year
1 year
number of days hospitalized immediately after surgery
大体时间:at discharge from hospital
at discharge from hospital
Time to recurrence of tumor or other pathology for which procedure was performed
大体时间:at recurrence of tumor or pathology
at recurrence of tumor or pathology
Time from start of treatment to death
大体时间:at time of death
at time of death

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Richard V Smith, MD、Montefiore Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年7月1日

初级完成 (实际的)

2014年6月1日

研究完成 (预期的)

2017年12月1日

研究注册日期

首次提交

2008年2月5日

首先提交符合 QC 标准的

2008年2月29日

首次发布 (估计)

2008年3月3日

研究记录更新

最后更新发布 (估计)

2016年3月17日

上次提交的符合 QC 标准的更新

2016年3月15日

最后验证

2016年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 07-03-080

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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