A Prospective, Single-Center Investigation of the Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Success rate (%)
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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
Outcomes
Primary Outcomes
Success rate (%)
Time Frame: immediately after the surgery
Calculating the percentage of cases successfully performed using the da Vinci SP system via the SP access port with or without an additional 12mm assistant port. Conversion to laparoscopy or laparotomy will be considered as failure.
Secondary Outcomes
- Perioperative Parameters:Incision length(immediately after the surgery)
- Postoperative Parameters:Readmission and reoperation rate(Within 30days after the surgery)
- Postoperative Parameters:Time to discharge(Within 30days after the surgery)
- Perioperative Parameters:Time of surgery(immediately after the surgery)
- Perioperative Parameters: Estimated blood loss(immediately after the surgery)
- Perioperative Parameters:Robotic console time(immediately after the surgery)
- Perioperative Parameters: Type of anastomosis(immediately after the surgery)
- Postoperative Parameters:pain requirements(Within 30days after the surgery)
- Postoperative Parameters:Time to tolerate diets(Within 30days after the surgery)
- Postoperative Parameters:Time to flatus(Within 30days after the surgery)
- Perioperative Parameters: Blood transfusions(immediately after the surgery)
- Perioperative Parameters: Intra-operative Complications(immediately after the surgery)
- Postoperative Parameters:Pain score(Within 30days after the surgery)
- Perioperative Parameters:Total operative time(immediately after the surgery)
- Perioperative Parameters: Urine output(immediately after the surgery)
- Postoperative Parameters:Complications(Within 30days after the surgery)