Matthew Skancke, MD, Vincent Obias, MD. George Washington University Hospital
Objective: In 2017, an estimated 39,910 people will receive a new diagnosis of rectal cancer. While the baseline surgical management of advanced rectal cancer remains the total mesorectal excision; more recently treatment for early rectal cancer has evolved with data to support local excision. Lesions that are proximal and in the rectosigmoid junction are difficult to access with traditional rigid in-line Tamis platforms. The initial Flex Robotic System was developed for oropharyngeal pathology. As such the product was not a sealed system, and cannot maintain insufflation. The technology has now been modified and the FDA expanded the indication to include transanal visualization and access to the anus, rectum, and distal colon utilizing a sealed flexible robotic platform equipped with articulating surgical instrumentation and tactile feedback to address mid and upper rectal pathology. This is the initial data associated with the new Transanal Drive.
Description of Technology and Method of Use: The Flex Robotic System utilizes a multi-linked articulating scope with a high definition display allowing for navigation through non-linear physiology (near 180-degree mobility) that would obstruct traditional laparoscopic and robotic cameras. Once positioned, insufflation is established and the scope becomes rigid and fully articulating, flexible instruments are passed through two 3mm operating ports facilitating dissection and suturing. The device accommodates both proprietary and third-party instruments.
Preliminary Results: Four patients have successfully undergone transanal resection of rectal malignancy using the Flex Robotic System. The average age was 64 years and the average BMI was 35 kg/m2. Lesions averaged 10.5cm from the dentate line (as high as 13cm), the total operative time was less than two hours for all cases and a maximum of three instruments were required to complete the resection. Peripheral margins were negative for all specimens. Deep margins were negative for the three tubulovillous adenomas exhibiting dysplasia but positive for the single rectal stromal tumor. There were no intraoperative conversions, operative complications or postoperative readmissions.
Conclusions and Future Directions: The Flex Robotic System for Transanal Access provides a novel approach to middle and upper rectal pathology with short operative times and a low intraoperative conversion rate. This is the first data on the new transanal platform which can maintain pneumoperitoneum. Future studies looking at larger numbers are needed, but our initial four cases demonstrates the safety and feasibility of the system.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 91197
Program Number: ET012
Presentation Session: Emerging Technology Session (Non CME)
Presentation Type: Podium