HIPAA Compliant
ISO 27001 CertifiedActively Recruiting
Led by University of California, Davis · Updated on 2026-05-29
25
Participants Needed
1
Research Sites
N/A
Total Duration
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
A
Ankit Sarin, MD
P
Pallavi Vaidya, BPharm
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University of California, Davis
Lead Sponsor
University of California, San Francisco
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Single‑port robotic surgery (SP system) | Multi‑port robotic surgery (Xi system) |
|---|---|---|
| What it is | A single‑arm study evaluating a single‑port robotic surgical platform (Intuitive Da Vinci SP) for planned colorectal surgery | The standard multi‑port robotic approach using the Intuitive Da Vinci Xi system |
| Role in the study | Participants undergo colorectal surgery using the SP device and investigators track safety and quality event rates | This method is not used in the trial but represents the routine surgical approach replaced by the SP system in this investigation |
| Why used | To evaluate the feasibility, safety, and quality event rate of SP robotic surgery in colorectal operations | Established minimally invasive robotic surgery method routinely used for colorectal operations |
| How it is performed | Single‑port access via Da Vinci SP system for transabdominal or transanal colorectal surgery | Multi‑port access using Da Vinci Xi robotic system in routine colorectal surgery |
| Evidence status | Early safety and feasibility being assessed; evidence still emerging | Short‑term outcomes have been compared in observational studies with mixed results |
| Safety concerns | Not yet fully established; trial will assess safety and quality events | Observed complication rates similar between SP and MP in limited real‑world reports |
| Important limitations | Findings are limited to early feasibility and safety in a single‑arm study; no direct randomized comparison | Evidence comes from observational comparisons with low certainty and risk of bias |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Have more questions? Get in touch with our team for quick support
Ankit Sarin, Katherine E Barnes, Amy M Shui...
https://pubmed.ncbi.nlm.nih.gov/39250792/University of California, Davis
Lead Sponsor
University of California, San Francisco
Collaborating Sponsor
