Colorectal Neoplasms
Conditions
Keywords
Colorectal Cancer, Robotic Surgery
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
Interventions
Colorectal surgery using the da Vinci SP System will be performed via the umbilicus, McBurney's site or the reverse McBurney's site depending on the sites of lesion. 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.
Sponsors
Chang Gung Memorial Hospital
Intuitive Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate (%) | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Parameters:Time to discharge | Within 30days after the surgery | Time to discharge |
| Postoperative Parameters:Complications | Within 30days after the surgery | Clavien-Dindo Classification |
| Postoperative Parameters:Readmission and reoperation rate | Within 30days after the surgery | Readmission and reoperation rate |
| Perioperative Parameters:Incision length | immediately after the surgery | Incision length |
| Perioperative Parameters:Time of surgery | immediately after the surgery | Time of surgery |
| Perioperative Parameters:Total operative time | immediately after the surgery | Total operative time |
| Perioperative Parameters:Robotic console time | immediately after the surgery | Robotic console time |
| Postoperative Parameters:Time to flatus | Within 30days after the surgery | Time to flatus |
| Perioperative Parameters: Estimated blood loss | immediately after the surgery | Estimated blood loss |
| Perioperative Parameters: Intra-operative Complications | immediately after the surgery | Satava System |
| Perioperative Parameters: Urine output | immediately after the surgery | Urine output |
| Perioperative Parameters: Type of anastomosis | immediately after the surgery | How the anastomosis was performed and method of construction |
| Postoperative Parameters:pain requirements | Within 30days after the surgery | type, frequency, total amount of narcotics used postoperatively per day |
| Postoperative Parameters:Pain score | Within 30days after the surgery | NRS |
| Postoperative Parameters:Time to tolerate diets | Within 30days after the surgery | time to tolerate clear liquids and solid food |
| Perioperative Parameters: Blood transfusions | immediately after the surgery | Blood transfusion amount |
Countries
Taiwan
Outcome results
None listed