Actively Recruiting
Led by University of California, Davis · Updated on 2026-05-29
25
Participants Needed
1
Research Sites
N/A
Total Duration
U
University of California, Davis
Lead Sponsor
U
University of California, San Francisco
Collaborating Sponsor
Researchers are evaluating the use of a novel Single Port (SP) Robotic Platform for colorectal surgery procedures. This study compares the safety and quality of colorectal surgeries performed with the SP platform against those done using the traditional Multi-port (Xi) robotic system. The goal is to assess whether the SP technology can be used effectively and safely for both transabdominal and transanal colorectal operations. Participants will undergo colorectal surgery using the Intuitive Da Vinci Single Port SP system, with surgical procedures determined by standard clinical care. The study tracks perioperative outcomes to compare them with cases performed using the Multi-port Xi system. This is an open-label, non-randomized study conducted at a single center, focusing on feasibility and quality of the SP platform. During the study, researchers will monitor clinical parameters including safety and quality events within 30 days after surgery. Participants must provide informed consent and comply with study requirements, including follow-up assessments. The study aims to gather detailed data to evaluate the surgical outcomes and safety profile of the SP robotic technology in colorectal surgery over the course of the trial.
CONDITIONS
Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo the colorectal surgical procedure using the Single Port Robotic Platform as part of routine clinical care.
1 surgical procedure visit and immediate post-operative assessments
Duration - 30 days
Participants are monitored for safety and quality outcomes following surgery.
Approximately 2 to 3 follow-up visits during the 30-day period
Total: 1 location
1
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
A
Ankit Sarin, MD
P
Pallavi Vaidya, BPharm
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Ankit Sarin, Katherine E Barnes, Amy M Shui...
https://pubmed.ncbi.nlm.nih.gov/39250792