Feasibility and Safety of Single Port Robot in Colorectal Procedures

Marks Colorectal Surgical Associates

Status: Unknown

Conditions: Prolapse, Rectal; Colon Cancer; Rectal Polyp; Colon Polyp; Inflammatory Bowel Diseases; Diverticulitis; Rectal Cancer

Treatments: Device: Single Port Robotic Colorectal Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT03700593

F/N-R19-3864L

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Single Port Robotic Colorectal Surgery Patients

Description:

All patients who undergo a single port robot colorectal surgery.

Treatment:

Device: Single Port Robotic Colorectal Surgery