Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures
Status
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Details and patient eligibility
About
The study is a prospective, single-center, single-arm unblinded clinical investigation. The aim of this study is to evaluate the performance and safety of da Vinci SP system. 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 performance and safety of this surgical option.
All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the above study. All of these patients will undergo a standard minimally invasive resection in the same fashion as would be carried out with multiport laparoscopic or robotic surgery
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age ≥18 years
- Pathological confirm of colon or rectal cancer
- Clinical stage I-III
- Patient is a candidate for minimally invasive right hemicolectomy or anterior resection.
- ASA ≤3
- Performance status: ECOG 0-1
Exclusion criteria
- Emergency surgery
- Patient has metastatic disease
- Patient has a bleeding or clotting disorder
- Uncontrolled illness, including active infection, symptomatic heart failure, unstable angina or cardiac arrhythmias, or psychiatric illness that would limit compliance with study requirements
- Previous laparotomy history
- Patient unable to provide informed consent
- Patient is pregnant
- BMI 35.0 or higher
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Chien-Chang Lu, MD
Data sourced from clinicaltrials.gov
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