Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
Summary
Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been widely used in colorectal surgery. This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications.
Detailed description
This is a single center, prospective, open-label, investigator initiated, non-randomized, interventional case-control study where researchers will study colorectal surgical procedures done using the novel Single Port (SP) Robotic Platform and compare perioperative outcomes to colorectal surgical cases done using the traditional Multi-port (Xi) Robotic Platform. AIM 1 To assess the feasibility and safety/quality of a SP platform for transabdominal and transanal colorectal operations which are currently done using multiport robotic platforms. AIM 2 To evaluate safety and quality outcomes post SP surgery in comparison with contemporaneous standard multiport Xi platform procedures.
Arms & interventions
- DeviceSingle port robotic colorectal surgical procedure
After screening and counseling, study subjects who wish to participate will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the alternate Intuitive Da Vinci Single Port SP system rather than the currently used multiport system, (Intuitive Da Vinci Multiport Xi System). Using standardized case report forms, the investigators will track clinical parameters and describe the safety \& quality event rate for SP platform transabdominal and transanal colorectal operations.
Outcome measures
Primary
Assess safety & quality event rate for SP platform transabdominal and transanal colorectal operations
A safety \& quality event will be defined as occurring if any of the following occur: * Conversion to open or laparoscopic procedure * EBL \> 200 ml, or * Operative time \> 90th percentile of all procedures with matching CPT code, or * Positive pathological margins (if applicable), or * Fragmented specimen (if applicable) or * Unplanned ICU stay or * Post-procedure LOS \> 90th percentile of all procedures with matching CPT code, or * Reoperation within 30 days or * Post Procedure Pain \> 90th percentile (visual analog score) * Postoperative complication as defined by NSQIP (including SSI, DVT, PE, readmission, anastomotic Leak (if applicable)
Time frame: 30 days
Eligibility criteria
Study locations (1)
UC Davis Medical Center
Sacramento, California, 95817
References
- Sarin A, Barnes KE, Shui AM, Nakamura Y, Hoffman DB, Romero-Hernandez F, Chern H. Initial Experience With Single-Port Robotic Right Colectomies: Results of an Investigator-Initiated Investigational Device Exemption Study Using a Novel Single-Port Robotic Platform. Dis Colon Rectum. 2024 Oct 1;67(10):e1600-e1606. doi: 10.1097/DCR.0000000000003352. Epub 2024 Sep 5.(PubMed)