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临床试验/NCT03700593
NCT03700593Unknown不适用

Feasibility and Safety of Single Port Robot in Colorectal Procedures

Marks Colorectal Surgical Associates1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Feasibility of the SP robot

研究概览

简要总结

The purpose of this study is to evaluate the safety and feasibility of using the Single Port (SP) robot (daVinci, Intuitive Surgical) to perform single port robotic colon surgery and transanal robotic surgery. The hypothesis of the study is that the SP robot will prove a safe effective modality to perform these procedures.

详细描述

In the colorectal arena, the robotic approach for benign and malignant disease is well established, with a great deal of literature generated regarding the safety and benefits of a colorectal robotic approach for benign and malignant disease. The section of colorectal surgery at the Lankenau Medical Center has been an active and robust contributor to surgical literature on laparoscopic surgery, robotic colorectal surgery, and single port laparoscopic surgery. Its one investigator has been involved in the development of clinical applications to the single port robotic platform where this has been utilized in cadaver work that has been published. Recently, the SP robot has gone through FDA clearance and is now available for clinical utilization. The FDA approval is for urologic surgery. The SP robot will be utilized in the same fashion to perform the same colorectal operations that the investigators have been performing with multiple port placements in the past to accomplish robotic surgery in a single port platform in the colorectal arena. The principal investigator has worked on the SP robot over the past 3 years with extensive cadaver experience to develop its safe application in the colorectal field. This study will entail a collection of demographics, preoperative, perioperative and postoperative outcomes of the patients into a database to follow this, report on the outcomes, and notably answer questions to demonstrate the feasibility and safety of this approach in colorectal patients.

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
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the study.

排除标准

  • emergency surgery
  • inability to offer informed consent
  • pregnant patients

结局指标

主要结局

Feasibility of the SP robot

时间窗: 30 days

Calculating the percentage of cases successfully performed using the SP robot, without conversion.

Rate of postoperative complications and mortality of the SP robot

时间窗: 30 days

Measuring the post-operative morbidity and mortality will be used to evaluate the safety of the SP robot.

次要结局

  • Assessment of patients' satisfaction with their surgical scars using validated questionnaires.(1 year)
  • Assessment of patients' postoperative body image satisfaction(1 year)
  • Assessment of patient's quality of recovery(1 year)
  • Assessment of patients quality of life using validated questionnaires.(1 year)

研究者

发起方
Marks Colorectal Surgical Associates
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. John Marks

Chief of Colorectal Surgery

Marks Colorectal Surgical Associates

研究点 (1)

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