NCT03700593

Feasibility and Safety of Single Port Robot in Colorectal Procedures

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Marks Colorectal Surgical Associates · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colon Cancer
• Colon Polyp
• Rectal Cancer
• Diverticulitis
• Prolapse, Rectal
• Rectal Polyp
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DEVICE	Single Port Robotic Colorectal Surgery	Single Port Robotic Colorectal Surgery

Timeline

• Start date: 2018-10-15
• Primary completion: 2020-10-01
• Completion: 2020-12-31
• First posted: 2018-10-09
• Last updated: 2020-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study