跳至主要内容
临床试验/NCT00774865
NCT00774865已完成不适用

Long Term Follow-up of Robotic Assisted Surgical Revascularization With CT Angiography

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
To determine the 5-7 year patency rate of the LITA graft of patients who have already had robotically-assisted CABG surgery using CTA and MPS-MIBI

研究概览

简要总结

The objectives of the 2-year study are two-fold:

  1. To determine the 5-7 year patency rate (rate of open bypass grafts) of the LITA graft of patients who have already had robotically-assisted CABG surgery using CTA and MPS-MIBI
  2. To determine patient quality of life at 5-7 years after robotically-assisted CABG surgery

详细描述

New techniques such as robotically-assisted CABG surgery need proper evaluation to ensure potential benefits gained are not harmful to that which we know to be of significant benefit to the patients, that being the left internal thoracic artery (LITA) graft (one of the main coronary arteries supplying your heart with blood). We are therefore proposing a 5-7 year CT-Angiography (CTA) and Myocardial Perfusion Scintigraphy (MPS-MIBI) to assess the patency rate of the LITA graft in patients that have already undergone robotically assisted CABG.

Between September 1999 and December 2001, a single surgeon performed robotically-assisted CABG surgery with LITA-to-LAD anastomosis on 151 patients with single vessel coronary artery disease at the London Health Sciences Centre, University Hospital. Patient consent and Research Ethics approval from The University of Western Ontario was acquired prior to each procedure. Sixty-one patients had robotically-assisted CABG surgery using the Automated Endoscopic Stabilizer for Optimal Positioning (AESOP) 3000 (Computer Motion, Goleta, CA), while 90 patients had robotically-assisted CABG surgery using the Zeus telemanipulation surgical system (Computer Motion, Goleta, CA). The AESOP 3000 is a single-arm robot that facilitates video thoracoscopic LITA dissection by providing steady images and voice-activated camera control. The Zeus telemanipulation surgical system is a multi-arm robotic telemanipulator that incorporates AESOP and allows control of surgical instruments within the thorax from a distant console.

Postoperative angiography was completed prior to discharge whenever possible. Patients continue to be followed on an annual basis. Our intent to perform follow-up angiography and MPS-MIBI at 5 and 10 years duration to assess LITA graft performance was discussed with each patient at the time of the original surgery. Two late deaths unrelated to surgery have been recorded in this cohort.

The 2-year study will be divided into three phases: Phase I - Patient Recruitment (4 months), Phase II - Patient Assessment with CTA, MPS-MIBI and Questionnaires (16 months) and Phase III - Data Analysis and Conclusions (4 months).

Phase I - Chart Review and Patient Recruitment (4 Months) Upon receiving approval from the Research Ethics Board at The University of Western Ontario, charts will be reviewed on all 151 robotically-assisted CABG surgery patients. Data on these patients is currently stored in a regularly updated database at our institution; however, a thorough review of all charts will be performed. Patient demographics and operative notes, as well as perioperative and postoperative complications will be reviewed. Hospital admissions, documented cardiac events and any subsequent deaths not previously documented will be recorded. Any additional pertinent data from the chart review will be entered into a study specific Microsoft Excel file maintained by a single qualified research assistant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have had previous robotically-assisted CABG surgery with a LITA to LAD anastomosis with either AESOP or Zeus performed between September 1999 and December 2001 at the London Health Sciences Centre
  • Willing to give informed consent to participate in the study

排除标准

  • Unable or unwilling to give informed consent
  • History of allergic reaction to contrast material used in CTA or severe adverse reactions to medications used in MPS-MIBI procedures

结局指标

主要结局

To determine the 5-7 year patency rate of the LITA graft of patients who have already had robotically-assisted CABG surgery using CTA and MPS-MIBI

时间窗: 5-7 years post robotic assisted CABG

次要结局

  • To determine patient quality of life at 5-7 years after robotically-assisted CABG surgery(5-7 years post robotic assisted CABG)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Long Term Follow-up of Robotic Assisted Surgical... | 临床试验