A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Intuitive Surgical
- Enrollment
- 60
- Locations
- 9
- Primary Endpoint
- Performance
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy.
Detailed Description
Primary Performance: * The primary performance endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. Conversion\* to an alternate approach comprises conversion to open, multiport laparoscopic\*\*, multiport robotic or hand-assisted§ approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach. * Performing an extracorporeal anastomosis is not considered a conversion \*\* Use of additional assistant laparoscopic port(s) is not considered a conversion § Laparoscopic or robotic with hand assistance Primary Safety: • The primary safety endpoint will be assessed as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •Candidate for single-port robotic-assisted surgery for low anterior resection with or without total mesorectal excision or right colectomy procedures
- •Willing and able to provide a written informed consent document
- •Willing and able to comply with the study protocol requirements including perioperative follow-up examinations at 14 days, 42 days post operatively, and post-market long-term follow-up on an annual basis through 5 years
Exclusion Criteria
- •Clinical or radiological evidence of metastatic disease
- •Life expectancy less than 6 months
- •Cancer of the anal canal requiring an abdominoperineal resection
- •Subjects with threatened mesorectal margins (≤1 mm) on MRI or ultrasound (for LAR ONLY)
- •Subjects with planned major concomitant procedures (eg. hepatectomaies, other intestinal resections) or emergent case
- •Subjects undergoing both LAR/TME and right colectomy during the same operation
- •Preoperative colonoscopy demonstrating synchronous colorectal cancer
- •History of inflammatory bowel disease
- •Subject has a known bleeding or clotting disorder
- •Uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Outcomes
Primary Outcomes
Performance
Time Frame: IntraOperative period
Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.
Adverse Events Rates
Time Frame: Intraoperative through the 42-day postoperative period
Safety defined as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period