Feasibility and Safety of Single Port Robot in Colorectal Procedures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colon Cancer
- Sponsor
- Marks Colorectal Surgical Associates
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Feasibility of the SP robot
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Dr. John Marks
Chief of Colorectal Surgery
Marks Colorectal Surgical Associates
Eligibility Criteria
Inclusion Criteria
- •All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the study.
Exclusion Criteria
- •emergency surgery
- •inability to offer informed consent
- •pregnant patients
Outcomes
Primary Outcomes
Feasibility of the SP robot
Time Frame: 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
Time Frame: 30 days
Measuring the post-operative morbidity and mortality will be used to evaluate the safety of the SP robot.
Secondary Outcomes
- 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)